¹ This Ordinance applies to:

a.

medical devices and the associated accessories, as defined in Article 3;

b.

groups of products without an intended medical purpose in accordance with Annex 1.

² In this Ordinance, the term devices is used to designate the products defined in paragraph 1.

³ This Ordinance also applies to:

a.

devices which, when placed on the market or put into service, incorporate as an integral part a medicinal product that has an action ancillary to that of the device;

b.

devices intended to deliver a medicinal product;

c.

devices manufactured:

1.

from tissue or cells of animal origin or their derivatives which are non-viable or have been rendered non-viable,

2.

from derivatives of tissue or cells of human origin that are non-viable or have been rendered non-viable;

d.

devices which, when placed on the market or put into service, incorporate as an integral part non-viable tissue or non-viable cells of human origin or their derivatives that have an action ancillary to that of the device;

e.

devices that incorporate as an integral part an in vitro diagnostic medical device; such constituent parts shall be subject to the provisions for in vitro medical devices.

¹ This Ordinance does not apply to:

a.

human blood, blood products, plasma or blood cells of human origin, or devices which, when placed on the market or put into service, incorporate such blood products, plasma or cells with the exception of the devices specified in Article 1 paragraph 3 letter a;

b.

vital organs, tissues or cells and transplant products of human origin;

c.

vital organs, tissues or cells and transplant products of animal origin;

d.

any items other than those listed in letters a-c that are composed of or contain viable biological substances or viable organisms, including living micro-organisms, bacteria, fungi or viruses, in order to achieve or support the intended purpose of the device;

e.

in vitro diagnostic medical devices; these are subject to Articles 105 and 107;

f.

non-separable combinations of a medicinal product and device intended to deliver a medicinal product that are intended solely for use in this combination and are not reusable;

g.

combinations which, when placed on the market or put into service, incorporate as an integral part a medicinal product in addition to the device, where the medicinal product assumes a primary function in such combinations;

h.

combinations which, when placed on the market or put into service, incorporate as an integral part non-viable tissue or non-viable cells of human origin or their derivatives in addition to the device, where such tissue, cells or derivatives assume a primary function in the device;

i.

medical devices intended solely for use in animals or veterinary diagnostics.

² In the cases specified in paragraph 1 letters f-h, the part of the combination that fulfils the role of device must satisfy the general safety and performance requirements set out in Article 6.

¹ Medical devices are instruments, apparatus, appliances, software, implants, reagents, materials or other objects:

a.

that are intended by their manufacturer for use in human beings;

b.

that do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which action can be assisted by such means; and

c.

that serve to fulfil one or more of the following specific medical purposes either alone or in combination:

1.

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

2.

diagnosis, monitoring, treatment, alleviation or compensation of injuries or handicaps,

3.

investigation, replacement or modification of the anatomy or of a physiological or pathological process or condition,

4.

acquisition of information by means of in vitro investigation of samples obtained from the human body, including donated organs, blood or tissue.

² Medical devices also include:

a.

contraceptive or fertility-enhancing products;

b.

items intended specifically to clean, disinfect or sterilise the devices listed in Article 1, paragraph 1 and in paragraph 1 of this Article.

³ Medical device accessory means any article that is not a medical device in its own right, but which is intended by its manufacturer to be used together with one or more particular medical devices and:

a.

which makes it possible to use the medical device or devices in accordance with its or their intended purpose; or

b.

which specifically and directly supports the medical function of the medical device or devices in line with its or their intended purpose.

¹ In this Ordinance:

a.

making available on the market means any supply of a device, other than an investigational device, for distribution, consumption or use on the Swiss market in the course of a commercial activity, whether in return for payment or free of charge;

b.

placing on the market means the first making available of a device, other than an investigational device, on the Swiss market;

c.

putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Swiss market for the first time for its intended purpose;

d.

maintenance means measures such as mechanical maintenance, software updates, inspection, repair, preparation for first use and reprocessing for reuse or measures to keep a device in functional condition or restore it to functional condition;

e.

reprocessing means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, particularly packing, transport and storage, as well as testing and restoring the technical and functional safety of the used device;

f.

manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark; this definition is subject to the clarifying explanations and exceptions in Article 16 paragraphs 1 and 2 of Regulation (EU) 2017/745⁷ on medical devices (EU-MDR);

g.

authorised representative means any natural or legal person domiciled in Switzerland who has received and accepted a written mandate from a manufacturer located in another country to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Ordinance;

h.

importer means any natural or legal person established within Switzerland that places a device from a foreign country on the Swiss market;

i.

distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the Swiss market, up until the point of putting into service;

j.

economic operator means the manufacturer, authorised representative, importer, distributor or natural or legal person as specified in Article 22 paragraphs 1 and 3 EU-MDR;

k.

healthcare facility means any organisation whose primary purpose is to provide care or treatment for patients or to promote public health;

l.

hospital means any healthcare institution in which inpatient treatments for illnesses, inpatient medical rehabilitation and inpatient medical measures for cosmetic purposes are provided by medical or nursing interventions;

m.

contracting state means any state that is bound to mutually recognise conformity assessments and conformity procedures for devices by an agreement with Switzerland under international law based on equivalent legislation.

² The definitions set out in Article 2 numbers 3-26, 31, 37, 38, 40-44, 46, 48, 51-53, 57-69 and 71 EU-MDR, taking account of the amendments to the definitions in Article 2 numbers 18-21 EU-MDR, effected by the European Commission by means of delegated acts⁸.

¹ The equivalent terms specified in Annex 2 and as used in EU-MDR⁹ and this Ordinance shall apply.

² Where this Ordinance makes reference to provisions of EU-MDR that in turn refer to other provisions of EU-MDR or other EU acts of law, those provisions shall also apply. The interpretation in the footnote to Article 4 paragraph 1 letter f is authoritative for references to EU-MDR, while the interpretations of the relevant EU act set out in Annex 3 number 1 apply to references to other EU acts. This provision excludes onward references to the EU acts listed in Annex 3 number 2; here the Swiss terms listed in the Annex shall apply.

¹ A device may be placed on the market or put into service only if it complies with this Ordinance when duly supplied and properly installed, maintained and used in accordance with its intended purpose.

² Devices must conform to the general safety and performance requirements set out in Annex I to EU-MDR¹⁰, taking account of their intended purpose.

³ Appropriate evidence that the part of the combination that is deemed to be a device under the cases set out in Article 2 letters f-h fulfils the product requirements must be presented to the competent authority on demand.

⁴ Compliance with the essential requirements of this Ordinance, as covered by designated technical standards¹¹, common specifications or prescriptions of the pharmacopoeia¹², is presumed if the device is in conformity with these standards, specifications or prescriptions.

⁵ The presumption made in paragraph 4 also applies to compliance with the system or process requirements that economic operators must comply with under this Ordinance, including requirements associated with quality management systems, risk management, post-market surveillance systems, clinical trials, clinical evaluation or post-market clinical follow-up.

⁶ Compliance with the common specifications in paragraph 4 is required unless the manufacturer can provide appropriate proof that the solutions it has chosen guarantee equivalent conformity with the safety and performance requirements. The above is subject to Article 8 paragraph 1.

¹ Devices marketed by means of information society services - specifically an online service - that fulfil the conditions set out in paragraph 4 must comply with this Ordinance.

² Similarly, devices that are not placed on the market but are used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services or by other means of communication must also comply with this Ordinance.

³ Upon request by the Swiss Agency for Therapeutic Products (Swissmedic), any natural or legal person offering a device in accordance with paragraph 2 or providing a service must be able make available a copy of the declaration of conformity.

⁴ A device is deemed to be supplied via an information society service if that service:

a.

is provided by distance selling, specifically without the contracting parties being physically present at the same time;

b.

is provided electronically; and

c.

is provided at the individual request of the recipient or the recipient's representative.

⁵ To protect public health, Swissmedic may require a provider of information society services to discontinue its activities in Switzerland.

¹ Devices without an intended medical purpose in accordance with Article 1 paragraph 1 letter b must comply with the common specifications stipulated by Swissmedic.

² Devices that have both a medical and non-medical intended purpose must fulfil both the requirements for devices with a medical intended purpose and the requirements for devices without an intended medical purpose.

³ Devices that are also machines within the meaning of Article 1 of the Machine Ordinance of 2 April 2008¹³ must satisfy the pertinent general safety and health protection requirements of the Machine Ordinance where these requirements are more specific than those of Chapter II of Annex I to EU-MDR¹⁴.

¹ Devices manufactured and used solely within healthcare institutions are deemed to have been put into service. Such devices are subject to the pertinent general safety and performance requirements of Annex I to EU-MDR¹⁵ but not to any of the other requirements set out in this Ordinance, provided the requirements of Article 5 paragraph 5 letters a-h EU-MDR are fulfilled.

² Paragraph 1 does not apply to devices manufactured on an industrial scale.

¹ Custom-made devices are subject to the requirements of Annex XIII to EU-MDR¹⁶. The declaration according to Section 1 of Annex XIII to EU-MDR must be enclosed when the devices are placed on the market.

² In addition to the procedure under paragraph 1, manufacturers of class III implantable custom-made devices must also conduct a conformity assessment procedure as specified in Chapter I of Annex IX to EU-MDR. Alternatively, they may opt for a conformity assessment in accordance with Part A of Annex XI to EU-MDR.

³ Manufacturers must create and update the documentation specified in Section 2 of Annex XIII to EU-MDR and ensure it can be made available to the competent authorities.

¹ The requirements of Articles 22 and 29 paragraph 2 EU-MDR apply to the placing on the market of systems and procedure packs¹⁷.

² Any natural or legal person who sterilises systems or procedure packs for placing on the market must apply a conformity assessment procedure for the sterilisation process and involve in that procedure a conformity assessment body that is designated under this Ordinance or recognised under an international agreement (designated body). The modalities for doing so are governed by Article 22 paragraph 3 EU-MDR.

³ Any natural or legal person who places the following systems or procedure packs on the market must fulfil the obligations of a manufacturer under Articles 46-50 and conduct the pertinent conformity assessment procedure under Article 23: Systems or procedure packs that:

a.

contain devices that do not carry a conformity marking;

b.

consist of a combination of devices that is not compatible with their original intended purpose; or

c.

have not been sterilised in accordance with the manufacturer's instructions.

¹ Any natural or legal person who makes available on the market an item intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence must be kept available for the competent authority.

² An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Ordinance.

¹ Devices placed on the market in Switzerland or made available on the Swiss market must bear a conformity marking in accordance with Annex 5. The conformity marking presented in Annex V to EU-MDR¹⁸ is also a permissible conformity marking.

² The following must not bear a conformity marking:

a.

custom-made devices;

b.

devices exclusively for demonstration and exhibition purposes;

c.

systems and procedure packs;

d.

investigational devices, subject to the provisions of Article 6 of the Ordinance of 1 July 2020¹⁹ on Clinical Trials with Medical Devices;

e.

devices manufactured and used in healthcare institutions.

³ Where devices' conformity has to be assessed by a designated body, the identification number of this body must be appended to the conformity marking.

¹ The conformity marking and, where necessary, associated identification number must appear on the device itself or on its sterile packaging.

² Where this is not possible or practicable owing to the composition of the device, the conformity marking and, where necessary, identification number must be displayed on the packaging.

³ The conformity marking must also appear on the instructions for use and trade packaging.

⁴ The requirements of Article 20 paragraphs 3-6 EU-MDR²⁰ and the general principles of Regulation (EC) No. 765/2008²¹ must also be observed when affixing the conformity marking.

¹ Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. This classification must comply with the provisions of Annex VIII to EU-MDR²².

² The procedure for resolving disputes between the manufacturer and a designated body as regards the classification of a device is governed by Article 51 paragraph 2 EU-MDR.

¹ Product information comprises the labelling and instructions for use. It is governed by Chapter III of Annex I to EU-MDR²³.

² It must be written in all three official languages of Switzerland. Symbols established by means of technical standards may be used to replace written statements.

³ The product information may be provided in fewer than the three official languages of Switzerland or in English, provided that:

a.

the device is supplied exclusively to professionals or is a custom-made device or a medical device manufactured and used in a healthcare institution;

b.

it is certain that the user meets the necessary professional and linguistic requirements and qualifications, and is in agreement;

c.

the protection of patients, users and third parties is ensured; and

d.

the efficacy and performance of the medical device are not placed at risk.

⁴ If requested, additional information must be provided to users in one of the official languages of Switzerland.

⁵ If a product cannot be, or cannot yet be, placed on the market as a medical device but may be confused with such a device, the claims relating to the said product must indicate clearly and legibly that it is not a medical device and is not suitable for medical purposes.

⁶ Devices intended solely for demonstration and exhibition purposes must be specifically labelled as such. The information must be clearly visible and comprehensible.

⁷ Misleading or contradictory information on a device's intended purpose, safety and performance is forbidden.

¹ Any manufacturer or natural or legal person who assembles systems and procedure packs in accordance with Article 22 paragraphs 1 and 3 EU-MDR²⁴ shall assign the product, system or procedure pack, with the exception of custom-made devices, and all superordinate packaging layers a unique device identifier (UDI²⁵) prior to placing it on the market.²⁶

² It must state the UDI on the labelling of the device, system or procedure pack and all superordinate packaging layers. Transport containers are not regarded as a superordinate packaging layer.²⁷

³ It shall maintain a list of all the UDIs it has assigned. This list is part of the technical documentation specified in Annex II to EU-MDR. It must be kept up-to-date at all times.²⁸

⁴ The obligations and modalities associated with product identification and registration are governed by Articles 27 and 29 and Annex VI to EU-MDR, taking account of the amendments to this Annex made by the European Commission by means of delegated acts²⁹.

⁵ ...³⁰

¹ Healthcare institutions that manufacture and use devices as specified in Article 9 shall provide the following information to Swissmedic prior to putting the devices into service:

a.

their name and address;

b.

the name and intended purpose of the device;

c.

the risk class of the device in accordance with Article 15 paragraph 1.

² Any other relevant information about these devices must be submitted to Swissmedic at Swissmedic's request. The declaration required under Article 5 paragraph 5 letter e EU-MDR³¹ must be made publicly available.

³ Changes to the information required in paragraph 1 must be reported to Swissmedic within 30 days.

⁴ Depending on the risk inherent in a device and its use, Swissmedic may exempt devices manufactured and used in accordance with Article 9 from the reporting obligation.

¹ Any natural or legal person who makes custom-made devices available on the Swiss market must provide the following information to Swissmedic before making the devices available:

a.

the name and address of the manufacturer and all manufacturing sites;

b.

the name and address of the authorised representative if applicable;

c.

the codes required to identify the relevant product categories, as specified by the European Commission by means of implementing acts³².

² Changes to this information must be reported to Swissmedic within 30 days of the changes taking effect.

³ Depending on the risk inherent in a device and its use, Swissmedic may exempt custom-made devices from the reporting obligation under paragraph 1.

¹ For implantable products, the manufacturer must provide, in addition to the product information required under Article 16, the information required under Article 18 paragraph 1 EU-MDR³³, including the implantation certificate. The exemptions specified under Article 18 paragraph 3 EU-MDR apply, taking account of the amendments adopted by the European Commission by means of delegated acts³⁴.

² The implantation certificate must be written in all three official languages of Switzerland.

³ Healthcare institutions must enter the details of the implant recipient in the implantation certificate and give the certificate to the recipient. They provide the essential information needed by the recipient in a quickly accessible form.

¹ Any natural or legal person who is domiciled in Switzerland and makes devices available on the market in Switzerland or in a contracting state must, upon request, provide the authorities responsible for controls as part of market monitoring with the declaration of conformity.

² Any natural or legal person who is domiciled in Switzerland and places a device on the market in Switzerland or in a contracting state or puts a device into service in Switzerland or in a contracting state without placing it on the market must carry out and be able to produce documentary evidence of an evaluation of the device's conformity with the general safety and performance requirements.

³ The demonstration of compliance with the general safety and performance requirements must also include a clinical evaluation in accordance with Article 61 EU-MDR³⁵.

¹ In response to a justified application, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of which is in the interests of public health or patient safety or health even though:

a.

the relevant conformity assessment procedure according to Article 23 has not been carried out; or

b.

the language requirements in Article 16 paragraph 2 have not been met.

² Individual devices that have not undergone the relevant conformity assessment procedure may be placed on the market and used without authorisation from Swissmedic provided:

a.

they serve to avert life-threatening conditions or to resolve the permanent impairment of a bodily function;

b.

no conforming device is available for this specific indication;

c.

they are used exclusively by healthcare professionals on individual persons;

d.

the healthcare professional using the device has informed the individual concerned about the non-conformity of the medical device and the related risks; and

e.

the individual concerned has consented to the use of the device.

³ For devices placed on the market exclusively within the armed forces or within the framework of their specific tasks, the Federal Department of Home Affairs (FDHA) may, in agreement with the Federal Department of Defence, Civil Protection and Sports, grant exemptions.

The conformity assessment procedure is governed by Articles 52 and 54 and by Annexes IX-XI to EU-MDR³⁶, taking account of the amendments to Article 52, paragraph 4, sub-paragraph 2 EU-MDR adopted by the European Commission by delegated act³⁷.

¹ When a designated body is involved, all the information necessary for the conformity assessment must be made available to it.

² Manufacturers must not apply to more than one designated body in Switzerland or a contracting state to conduct a conformity assessment procedure for the same product.

³ Any natural or legal person who applies to a designated body must inform that body whether an application to a different designated body in Switzerland or a contracting state has been withdrawn before a decision was issued or rejected by a different designated body in Switzerland or a contracting state.

⁴ If a manufacturer withdraws its application to have a conformity assessment procedure conducted before the designated body has issued its decision on the assessment, the designated body in question will notify Swissmedic and the other designated bodies.

⁵ The information required in paragraph 4 must be supplied exclusively via Eudamed.

⁶ Where a manufacturer voluntarily changes designated body, it must comply with the requirements of Article 58 EU-MDR³⁸.

¹ The designated bodies issue certificates of conformity in accordance with Annexes IX-XI to EU-MDR³⁹ (Certificates).

² The certificates must be issued in one of the three official languages of Switzerland or in English.

³ They must, as a minimum, include the information required in Annex XII to EU-MDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts⁴⁰.

⁴ Certificates issued by bodies designated under EU law and domiciled in an EU or EEA state but not recognised by an international agreement are deemed equivalent to certificates issued by Swiss bodies if it can be credibly demonstrated that:

a.

the conformity assessment procedures used meet Swiss requirements; and

b.

the certificates were issued by a body with an equivalent qualification to that required in Switzerland.⁴¹

¹ Certificates are valid for a maximum of five years. The expiry date must appear on the certificate.

² At the manufacturer's request, the validity of the certificate can be extended by a maximum of five years following a new assessment carried out in accordance with the relevant conformity assessment procedure. Certificates can be extended more than once.

³ Any addendum to a certificate is valid for the same period as the certificate to which it belongs.

¹ If a designated body finds that a manufacturer no longer fulfils the requirements of this Ordinance, it shall impose on that manufacturer a suitable deadline for restoring compliance.

² If this deadline passes without the manufacturer taking suitable corrective action, the designated body shall suspend, revoke or restrict the certificate in question.

³ A certificate that has been amended, suspended or revoked by a designated body must no longer be used in its original form.

¹ The designated body will provide Swissmedic and the other designated bodies with:⁴²

a.

all information on certificates it has issued and any amendments or addenda to such certificates;

b.

information on suspended, reactivated or revoked certificates;

c.

information on certificates it has rejected;

d.

information on restrictions imposed on certificates.

² It will also provide Swissmedic with information on whether or not a conformity assessment procedure should be applied in accordance with Article 54 paragraph 1 EU-MDR⁴³. Notifications of certificates for devices that have undergone a procedure of this type must include the documents specified in Article 55 paragraph 1 EU-MDR.⁴⁴

¹ If the applicable conformity assessment procedure has demonstrated that the requirements of this Ordinance have been fulfilled, the manufacturer of devices that are not custom-made or investigational issues a declaration of conformity. This declaration shall be subject to ongoing updating.

² The declaration of conformity must include the information required in Annex IV to EU-MDR⁴⁵, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts⁴⁶. It must be written in one of the three official languages of Switzerland or English or translated into one of these languages.

³ If a device also requires a manufacturer's declaration of conformity for aspects not covered by this Ordinance but nevertheless required by other legislation in order to demonstrate compliance with that legislation, one single declaration of conformity will be issued.

⁴ By issuing the declaration of conformity, the manufacturer assumes responsibility for ensuring that the device complies with the requirements of this Ordinance as well as with any other legislation to which the device is subject.

¹ Swissmedic will only designate conformity assessment bodies that have completed an assessment procedure in accordance with Article 34 and which satisfy the requirements set out in Annex VII to EU-MDR⁵².

² Applications for designation must be submitted to Swissmedic. They must in particular include:

a.

details of the activities and the types of product for which designation is sought;

b.

proof that the requirements of Annex VII to EU-MDR are met.

³ Swissmedic shall verify whether the application for designation is complete within thirty days, and request the applicant to submit any information that may be missing.

⁴ It shall review the application and accompanying documents and issue a preliminary assessment report.

¹ Swissmedic shall conduct an on-site assessment of the conformity assessment body and, if relevant, of all sub-contractors and subsidiaries.

² If Swissmedic identifies non-compliances in the course of its assessment, it shall draw up a list of non-compliances for the applicant. Swissmedic shall set the conformity assessment body a deadline by which the latter must submit to Swissmedic a corrective action plan to remedy the non-compliances and a plan setting out preventive measures.

³ The plans must indicate the root cause of the identified non-compliances and must include a timeframe for implementing the measures.

⁴ Swissmedic will decide whether the proposed action is suitable and whether the timeframe for implementation is appropriate.

¹ If Swissmedic approves the plans required under Article 34 paragraph 2, it shall prepare an assessment report.

² This shall comprise the following:

a.

the result of the assessment;

b.

confirmation that suitable corrective and preventive measures have been planned and where necessary implemented;

c.

the scope of the designation.

¹ Swissmedic shall grant the designation if the conformity assessment body meets the requirements.

² The extension of designations is subject to the requirements and procedures laid out in Articles 33-35.

¹ Designated bodies that delegate part of the work to sub-contractors or to a subsidiary bear full responsibility for the work carried out on their behalf by the sub-contractor or by the subsidiary.

² They must ensure that the sub-contractor or the subsidiary meets the applicable requirements of Annex VII to EU-MDR⁵³.

³ They must notify Swissmedic if they delegate work under the terms of paragraph 1. They must be able to demonstrate to Swissmedic that the sub-contractor or the subsidiary is capable of carrying out the tasks assigned to it.

⁴ Work may only be delegated if the designated body has notified the natural or legal person who requested the conformity assessment accordingly.

⁵ The designated bodies must publish a list of their subsidiaries.

¹ The designated bodies, including their subsidiaries and sub-contractors, are required to keep available for Swissmedic at all times all data that is necessary for assessment, designation, monitoring and re-assessment, including the documents required to assess the qualifications of sub-contractors or subsidiaries. The data must be kept up-to-date at all times.

² The designated bodies shall notify Swissmedic within 15 days of any change that affects their ability to meet the requirements of Annex VII to EU-MDR⁵⁴ or to carry out conformity assessments.

The designated bodies shall issue lists of the standard tariffs charged for their activities and make these lists publicly accessible.

¹ If a designated body ceases to carry out its conformity assessment activities, it shall notify Swissmedic and the manufacturers concerned as soon as possible. In the case of planned cessation of activities, notice must be given one year before the activities cease. Swissmedic will revoke the designation from the date on which the activities cease.

² The certificates will remain valid for a maximum of nine months following cessation of activities, provided another designated body assumes responsibility for certifying the products concerned and confirms this in writing.

³ The designated body assuming responsibility in accordance with paragraph 2 shall conduct a full assessment of the products concerned before the nine-month period expires and before issuing new certificates for the products.

¹ Designation shall be suspended, restricted or revoked if the designated body:

a.

no longer or only partly meets the requirements; or

b.

fails to carry out corrective action ordered by Swissmedic.

² Suspensions will be imposed for a maximum of twelve months. They may be extended by a maximum of a further twelve months.

³ If designation is suspended, restricted or revoked, the designated body must inform all affected manufacturers accordingly within ten days.

¹ In the event of its designation being restricted, suspended or revoked, the designated body will suspend or withdraw any certificates which were unduly issued.

² If the designated body fails to fulfil this requirement, Swissmedic will instruct it to suspend or revoke the certificates and set an appropriate deadline for doing so.

¹ If Swissmedic suspends or restricts the designation of a designated body, the certificates concerned remain valid provided Swissmedic:

a.

confirms within a month that no safety issue exists in connection with the products concerned; and

b.

outlines a timeline and measures to remedy the suspension or restriction.

² The certificates also remain valid if Swissmedic:

a.

confirms that, during the suspension or restriction, no certificates relevant to the suspension will be issued, amended or re-issued; and

b.

states that the designated body is able to continue to monitor and retain responsibility for existing certificates during the suspension or restriction.

³ The designated body shall notify the manufacturers concerned or the persons or entities placing the devices concerned on the market.

⁴ Should Swissmedic ascertain that the designated body is unable to continue to oversee existing certificates, these certificates will retain their validity if the manufacturer of the product in question confirms to Swissmedic or, if it is domiciled in a contracting state, to the competent authority there, in writing and within three months of designation being suspended or restricted that:

a.

another qualified designated body is temporarily assuming the oversight duties; and

b.

this designated body will be responsible for the certificates during the period of suspension or restriction.

¹ If Swissmedic revokes the designation of a designated body, the certificates affected remain valid for nine months provided:

a.

Swissmedic or, if the manufacturer is domiciled in a contracting state, the competent authority there confirms that the products in question present no safety issues;

b.

another designated body confirms in writing that it is assuming immediate responsibility for the certificates for these products and can complete the assessment of the products within twelve months of designation being revoked.

² Swissmedic may, within the limits of its competence, extend the provisional validity of the certificates for further periods of three months, which altogether must not exceed twelve months.

¹ Swissmedic shall monitor the designated bodies and their subsidiaries and sub-contractors and carry out re-assessments. In the course of monitoring and re-assessing designated bodies and reviewing their assessments, Swissmedic shall take account of the requirements and procedures set out in Articles 44 and 45 EU-MDR⁵⁵.

² It will verify whether designated bodies still satisfy the requirements of Article 36 paragraph 1 and Annex VII to EU-MDR three years after designation, and then every four years, in the course of a full re-assessment. This provision is subject to changes in assessment intervals resulting from delegated acts⁵⁶ issued by the European Commission.

³ Swissmedic will carry out an on-the-spot assessment at least once a year to ascertain whether the designated bodies and, if applicable, their subsidiaries and sub-contractors are fulfilling the requirements and obligations of Annex VII to EU-MDR.

⁴ For this purpose, it may at any time:

a.

carry out on-site assessments with or without advance notice;

b.

carry out audits of the employees of the designated body and its subsidiaries or sub-contractors or observe audits that the designated body carries out on manufacturers' premises.

¹ Manufacturers guarantee that their products have been designed and manufactured in accordance with the requirements of this Ordinance when they place them on the market or put them into service.

² They must print the conformity marking on their products.

³ They must conduct a clinical evaluation in accordance with Article 61 EU-MDR⁵⁷ taking account of the amendments to this Article adopted by the European Commission by means of delegated acts⁵⁸ and in accordance with Annex XIV to EU-MDR. They must update this clinical evaluation in line with the results of post-market clinical follow-up.

¹ Manufacturers must list in the technical documentation the information required in Annexes II and III to EU-MDR⁵⁹, taking account of the amendments to these Annexes made by the European Commission by means of delegated acts⁶⁰.

² Manufacturers must submit either the complete technical documentation or a summary of this documentation when requested to do so by the competent authority.

¹ Manufacturers must ensure that the following are available to the competent authority for at least ten years after the final product covered by the declaration of conformity has been placed on the market:

a.

complete technical documentation;

b.

declaration of conformity;

c.

a copy of the certificates issued, including any amendments and addenda.

² The document retention period for implantable products shall be at least 15 years from the date the last product was placed on the market.

¹ Manufacturers must have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.

² Proof that the person responsible for regulatory compliance possesses the requisite expertise, the responsibilities of this person, exceptions and further modalities are governed by Article 15 EU-MDR⁶¹.

³ The person responsible for regulatory compliance must have a deputy. If a number of persons are jointly responsible for regulatory compliance, their respective areas of responsibility shall be stipulated in writing.

⁴ The person responsible for regulatory compliance must suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of their duties, regardless of whether or not they are employees of the organisation.

The further obligations incumbent on manufacturers, particularly the requirements to be fulfilled by their quality and risk management systems, are governed by Article 10 EU-MDR⁶².

¹ Where the manufacturer of a device is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by means of a written mandate.

² The authorised representative is responsible for the formal and safety-related aspects of placing the device on the market.

³ The authorised representative's rights and obligations and the scope of its mandate are governed by Article 11 EU-MDR⁶³.

^3bis The manufacturer and authorised representative may contractually agree that instead of the authorised representative keeping available a copy of the technical documentation, the manufacturer shall, on request, submit the documentation straight to Swissmedic. The authorised representative must ensure that the documentation is submitted within seven days.⁶⁴

⁴ Changes in authorised representative are governed by Article 12 EU-MDR.

⁵ Paragraphs 1-4 also apply to natural or legal persons who assemble systems and procedure packs in accordance with Article 22 paragraphs 1 and 3 EU-MDR and who are not domiciled in Switzerland.⁶⁵

¹ Authorised representatives must ensure that they have permanently and continuously at their disposal at least one person who possesses the requisite expertise as regards the requirements for medical devices under this Ordinance and who is responsible for regulatory compliance.

² In other respects, Article 49 paragraphs 2-4 shall apply.

¹ Importers may only place on the market devices that comply with this Ordinance. Before placing devices on the market, they shall verify that:

a.

the device carries the conformity marking;

b.

the declaration of conformity has been drawn up;

c.

the manufacturer is identified and has designated an authorised representative in accordance with Article 51;

d.

the product is labelled in accordance with this Ordinance and accompanied by instructions for use;

e.

the manufacturer has assigned a UDI where applicable.

² Importers must print their name, place of business and contact address on the product, the product packaging or a document enclosed with the product.

³ Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not place the device on the market until it has been brought into conformity.

⁴ The further obligations of importers prior to and after placing a device on the market are governed by Articles 13 and 16 paragraphs 3 and 4 EU-MDR⁶⁶. In particular, importers must comply with the following obligations:

a.

storage, transport and quality management system;

b.

cooperation with the manufacturer, authorised representative, designated body and competent authorities;

c.

the provision of information to the manufacturer, authorised representative, designated body and competent authorities.

¹ When making a device available on the market, distributors must, in the context of their activities, act with due care in relation to the requirements applicable. Before making a device available on the market, distributors must verify that:

a.

the device carries the conformity marking;

b.

the declaration of conformity has been drawn up;

c.

the device is accompanied by product information;

d.

where devices have been imported the importer has provided the information required in Article 53 paragraph 2;

e.

the manufacturer has assigned a UDI where applicable.

² With the exception of paragraph 1 letter d, random sampling may be used for the purposes of verification.

³ Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Ordinance, it must not make the device available on the market until it has been brought into conformity.

⁴ The further obligations of distributors prior to and after making a device available on the market are governed by Articles 14 and 16 paragraphs 3 and 4 EU-MDR⁶⁷. In particular, distributors must fulfil the following obligations:

a.

storage, transport and quality management system;

b.

cooperation with the manufacturer, authorised representative, importer and competent authorities;

c.

the provision of information to the manufacturer, authorised representative, importer and competent authorities.

¹ Manufacturers or their authorised representatives and importers must register the information required by part A of Annex VI to EU-MDR⁶⁹ with Swissmedic within three months of placing a device on the market for the first time.

² The economic operator in question must report any changes to the information to Swissmedic within one week.

³ Further obligations and registration modalities are governed by Articles 30 paragraph 3 and 31 EU-MDR.

⁴ Swissmedic will verify the information provided by the economic operators and assign them a unique identification number.

⁵ Any natural or legal person placing systems and procedure packs on the market for the first time under Article 11 must register their name and the address at which they can be contacted with Swissmedic within three months of placing the system or procedure pack on the market. Where an authorised representative is required under Article 51 paragraph 5, the name and address of the authorised representative must also be registered with Swissmedic.

¹ For each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. This system forms an integral part of the manufacturer's quality management system.

² The system must be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

³ The modalities of the system, particularly the resulting actions, updates and amendments to technical documentation, are governed by Article 83 paragraph 3 EU-MDR⁷⁰.

¹ Should it become evident in the course of post-market surveillance that preventive and/or corrective action is necessary, manufacturers must take suitable steps, notifying the competent authorities and, if applicable, the designated body.

² If a manufacturer becomes aware of a serious incident in connection with a device that has been made available on the market, or takes action to prevent or minimise the risk of such an incident for medical or technical reasons (field safety corrective actions), it must report the fact in accordance with Article 66.

The post-market surveillance plan must satisfy the requirements of Section 1 of Annex III to EU-MDR⁷¹. With the exception of custom-made devices, the plan is part of the technical documentation specified in Annex II to EU-MDR.

¹ Manufacturers of class I devices must draw up a report on post-market surveillance.

² This report must contain:

a.

a summary of the results and conclusions of the analyses of the data gathered as a result of the plan specified in Article 58;

b.

a rationale and description of any preventive and corrective actions taken.

³ The report forms part of the post-market surveillance technical documentation specified in Annex III to EU-MDR⁷².

⁴ The manufacturer must update the report when necessary and make it available to the competent authority upon request.

¹ Manufacturers of class IIa, class IIb and class III devices shall prepare a safety report for each device and where relevant for each category or group of devices.

² Manufacturers of class IIa devices shall update the safety report when necessary and at least every two years. Manufacturers of class IIb and class III devices must update this report at least annually.

¹ The safety report must contain:

a.

a summary of the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan as specified in Article 58;

b.

a rationale and description of any preventive and corrective actions taken.

² Throughout the lifetime of the device concerned, the safety report must set out:

a.

the conclusions of the benefit-risk determination;

b.

the key results of post-market clinical follow-up;

c.

the total sales volume of the device;

d.

an estimate of the size of the population using the device;

e.

characteristics of the population in letter d;

f.

the frequency of device usage, where practicable.

³ The safety report forms part of the technical documentation specified in Annexes II and III to EU-MDR⁷³. For custom-made devices, the report forms part of the documentation specified in Section 2 of Annex XIII to EU-MDR.

¹ Manufacturers will make their safety reports available to the designated body involved in the conformity assessment.

² The designated body will review the safety report for class III devices or implantable devices and record the outcome of its review with details of any action taken.

³ Manufacturers or their authorised representatives will, upon request, make the safety report and the outcome of the designated body's review, with details of any action taken, available to the competent authority.

¹ For class III devices and for implantable devices, other than custom-made or investigational devices, the manufacturer must draw up a summary of safety and clinical performance.

² The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient.

³ The minimum content of the summary is governed by Article 32, Paragraph 32 EU-MDR⁷⁵.

⁴ The draft summary of safety and clinical performance must be submitted to the designated body involved in the conformity assessment pursuant to Article 24 for validation by that body.

⁵ The manufacturer will publish the summary after it has been validated.⁷⁶

⁶ The manufacturer must mention on the label or instructions for use where the summary is available.

¹ Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.

² The duty of disclosure under Article 47c TPA continues for at least 10 years, or for at least 15 years for implantable products, after the last product covered by the conformity assessment was placed on the market.

¹ Economic operators shall store and keep, preferably by electronic means, the UDI of the class III implantable devices which they have supplied or with which they have been supplied.

² Swissmedic may extend this obligation to other devices, or categories or groups of devices.

¹ Manufacturers of devices made available in Switzerland or natural or legal persons who assemble systems or procedure packs in accordance with Article 22 paragraphs 1 and 3 EU-MDR⁷⁷ must report to Swissmedic:

a.

any serious incidents involving the device in question that have occurred in Switzerland, as soon as they become aware of them;

b.

any field safety corrective actions undertaken in Switzerland.⁷⁸

² Exemptions from this reporting obligation, modalities, periodic summary reports, trend reporting and analyses of serious incidents and field safety corrective action are governed by Articles 27 paragraph 5 and 87-89 EU-MDR.

^2bis Where an authorised representative is required pursuant to Article 51, this representative is responsible for the reporting obligation in paragraph 1. Furthermore, the authorised representative must submit the trend reports pursuant to paragraph 2 on incidents in Switzerland and abroad to Swissmedic without being requested to do so. Final reports prepared in accordance with Article 89 paragraph 5 EU-MDR should be submitted to Swissmedic. The transfer of these obligations from the manufacturer or from the natural or legal person assembling systems or procedure packs under Article 22 paragraphs 1 and 3 EU-MDR to the authorised representative must be agreed in writing in the mandate.⁷⁹

³ ...⁸⁰

⁴ Any professional who becomes aware of an incident when using devices must report this to the supplier and Swissmedic. The report may be submitted by a professional association. The timelines for doing so are as set out in Article 87 EU-MDR.

⁵ Reports must be submitted to Swissmedic electronically and in machine-readable format. Swissmedic publishes information on electronic submission and the forms to be used with content specifications.

¹ Hospitals must set up an internal reporting system within the framework of an established quality management system for the purpose of reporting under Article 66 paragraph 4.

² They must designate a suitable competent person (vigilance contact person) with a medical or technical qualification to assume responsibility for reporting to Swissmedic. They must supply this person's contact details to Swissmedic.

³ Records and all documents created under the vigilance quality management system must be retained for at least 15 years.

Swissmedic and third parties contracted by Swissmedic are empowered to process the personal data that they need to perform the tasks mandated to them by this Ordinance. Specifically, this includes:

a.

health data acquired in the course of market surveillance and vigilance;

b.

data documenting the reliability and professional qualifications of vigilance contact persons (Art. 67 para. 2) or the individuals responsible for compliance with the regulations (Art. 49 and 52).

¹ It is Swissmedic's responsibility to ensure that its information systems operate securely and that data is processed in accordance with legal requirements.

² It will draw up a set of processing rules for each information system. These will specify the technical and organisational measures to be taken to ensure that the data is protected and secure.

¹ The following persons and agencies will be given online access to information systems provided this is necessary for the fulfilment of their respective tasks:

a.

Swissmedic staff employed in vigilance and market surveillance and third parties mandated to perform tasks in this area;

b.

Swissmedic staff employed in administrative penal law;

c.

Swissmedic administrators and mandated third parties.

² A log of persons and bodies granted access to the information systems will be kept. The data in this log will be stored for two years.

Personal data will be stored for a period of ten years from the final entry. On the expiry of this period, it will be destroyed.

Swissmedic is responsible for the medical devices information system required under Article 62c TPA (medical devices information system).

¹ Swissmedic shall draw up processing rules in accordance with Article 21 of the Ordinance of 14 June 1993⁸⁶ to the Federal Act on Data Protection (OFADP).

² Articles 20 and 21 OFADP apply to data security.

³ Data processing must be automatically logged.

¹ This medical devices information system contains the following data:

a.

device data;

b.

data on economic operators;

c.

data on the designated bodies and certificates issued by them;

d.

data on clinical trials;

e.

vigilance data;

f.

market surveillance data;

g.

data that can be used to manage and adapt the medical devices information system (system data);

h.

authentication data, assigned user roles and basic settings for using the medical devices information system (user data).

² The medical devices information system only contains personal data where such data is required to record and process information.

The medical devices information system can draw the data specified in Article 85 from Eudamed and from cantonal electronic systems; it can also submit data to Eudamed and cantonal systems.

Swissmedic has access to all data recorded in and processed by the medical devices information system.

¹ Data subjects' rights, particularly the right to information, rectification and deletion of data, are governed by data protection legislation.

² Swissmedic will ensure that data that is incorrect or has been processed unlawfully is corrected in or deleted from the medical devices information system. Correction and deletion will take place as quickly as possible, but no later than 60 days of the data subject making their request.

The personal data specified in Article 85 paragraph 2 must be stored in such a way that it is only possible to identify data subjects for a period of ten years after the last device covered by the declaration of conformity was placed on the market. For implantable devices, this period is extended to 15 years.

Swissmedic may publish the following in the medical devices information system:

a.

product data, as specified in accordance Part B of Annex VI to EU-MDR⁸⁷;

b.

information on economic operators and devices, as specified in Part A of Annex VI to EU-MDR;

c.

the general information specified in Article 35 paragraph 7 EU-MDR governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of designated bodies, and on changes that have a significant impact on such tasks;

d.

summaries of the annual report on monitoring and on-site assessment activities drawn up in accordance with Article 44 paragraph 12 EU-MDR;

e.

summaries of safety and clinical performance in accordance with Article 63;

f.

information on certificates issued under Articles 28 and 42-44;

g.

field safety notices for users or customers issued in the course of field safety corrective actions in accordance with Article 89 paragraph 8 EU-MDR;

h.

summaries of the reports on Swissmedic's activities in monitoring market surveillance;

i.

scientific opinions in accordance with Article 106 paragraph 12 EU-MDR;

j.

information on market monitoring activities, particularly recalls, on non-conforming devices and preventive health protection measures.

Non-personal data can be used for the independent assessment of long-term device safety or performance or of the traceability of implantable products.

All data processing activities carried out in the medical devices information system must comply with the Federal Act of 19 June 1992⁸⁸ on Data Protection.

¹ The FDHA can amend Annexes 1-3 to this Ordinance in line with international and technical progress.

² Where amendments may pose technical barriers to trade, it will effect them by mutual agreement with the Federal Department of Economic Affairs, Education and Research.

Swissmedic will provide on its website information on legal acts of the European Commission that, according to this Ordinance, are directly applicable in Switzerland in the version binding upon the Member States of the EU and as listed in Annex 4.

¹ When implementing this Ordinance, Swissmedic will respect the implementing acts adopted by the European Commission on the basis of EU-MDR⁸⁹.

² Regulations (EU) No 207/2012⁹⁰ and No 722/2012⁹¹ will remain in force until such time as they are repealed in the EU by implementing acts adopted by the European Commission on the basis of EU-MDR.

¹ Where provided for by international agreements, Swissmedic, the designated bodies and economic operators will cooperate with the European Commission and the authorities of the contracting states.

² Swissmedic can appoint experts who are qualified to evaluate conformity assessment bodies in the field of medical devices.

³ The Agency may appoint experts to participate in expert groups of the European Commission and the authorities of the contracting states.

¹ The customs authorities provide Swissmedic with information on the import, export and transit of devices.

² Swissmedic can mandate the customs authorities to detain devices for further inspection and to obtain samples.

¹ Laboratories that wish to be designated an expert laboratory by the European Commission in accordance with Article 106 paragraph 7 EU-MDR⁹² may apply to Swissmedic for designation.

² They must demonstrate to Swissmedic in particular that they:

a.

meet the criteria set out in Article 106 paragraph 8 EU-MDR; and

b.

are able to assume the tasks under Article 106 paragraph 10 EU-MDR, taking account of the amendments to this provision adopted by the European Commission by means of delegated acts⁹³, in accordance with the requirements in each case.

³ They must operate in one of the following fields:

a.

physico-chemical characterisation;

b.

microbiological, mechanical, electrical, electronic or non-clinical biological and toxicological testing or biocompatibility testing.

⁴ If the requirements are met, Swissmedic will propose to the EU Commission that the laboratory be designated an expert laboratory.

The following ordinances are repealed:

1.

the Medical Devices Ordinance of 17 October 2001⁹⁴;

2.

Ordinance of 22 June 2006⁹⁵ on the List of Prescription Medical Devices.

¹ Certificates issued under the old legislation prior to 25 May 2017 will retain their validity until the expiry date stated therein, but no longer than 26 May 2022.

² Certificates issued under the old legislation since 25 May 2017 will retain their validity until the expiry date stipulated in them, but no longer than 26 May 2024.

¹ Provided they continue to comply with the old legislation from 26 May 2021 and have not undergone any significant changes in their design or intended purpose, the following medical devices may be placed on the market or put into service until 26 May 2024:

a.

devices classified as class I under the old legislation for which a declaration of conformity was issued before 26 May 2021 and for which the conformity assessment procedure under this Ordinance necessitates the involvement of a designated body;

b.

devices with a certificate valid under Article 100.

² The post-market surveillance and market monitoring of these devices, vigilance, and registration of economic operators and of the devices themselves are subject to the provisions of this Ordinance.

³ Devices legally placed on the market prior to 26 May 2021 under the old legislation and devices placed on the market from 26 May 2021 under paragraph 1 can continue to be placed on the market or put into service until 26 May 2025. The above is subject to Article 103.

Exemptions issued by Swissmedic under Article 9 paragraph 4 of the Medical Devices Ordinance of 17 October 2001⁹⁶ shall retain their validity.

¹ Devices incorporating devitalised tissue or cells of human origin or their derivatives as specified in Article 1 paragraph 3 letter c no. 2 and d that were lawfully placed on the market or put into service prior to 26 May 2021 may still be placed on the market or put into service until 26 May 2025. Art. 101 paragraph 2 applies mutatis mutandis.

² Until such time as a corresponding special Ordinance is issued, devices covered by Article 2a paragraph 2 TPA are subject to the Medical Devices Ordinance of 17 October 2001⁹⁷. Devices covered by Article 2a paragraph 2 TPA that were lawfully placed on the market prior to 26 May 2021 may still be placed on the market or put into service until such time as a corresponding special Ordinance is issued.

The UDI required by Article 17 paragraph 2 must be affixed:

a.

for implantable and class III devices: from 26 May 2021;

b.

for class IIa and IIb devices: from 26 May 2023;

c.

for class I devices: from 26 May 2025;

d.

for reusable devices where the UDI has to be affixed to the product itself: two years after the dates given in letters a-c for the relevant product class.

¹ If the manufacturer is domiciled in an EU or EEA state, or if the manufacturer has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 51 paragraph 1 within the following time periods:

a.

for class III devices, class IIb implantable devices and active implantable devices: by 31 December 2021;

b.

for non-implantable class IIb devices and class IIa devices: by 31 March 2022;

c.

for class I devices: by 31 July 2022.

² For systems and procedure packs, an authorised representative in accordance with Article 51 paragraph 5 must be appointed by 31 July 2022.

Economic operators that have placed devices on the market prior to 26 May 2021 in accordance with Article 22a of the Medical Devices Ordinance of 17 October 2001¹⁰⁰ must register the information required under Article 55 paragraphs 1 and 5 by 26 November 2021.

¹ Until such time as a corresponding special Ordinance is issued, in vitro diagnostic medical devices are subject to the Medical Devices Ordinance of 17 October 2001¹⁰², subject to paragraphs 2 and 3.

² In vitro diagnostic medical devices must not carry the name and address of the natural or legal person who first places them on the Swiss market on their labelling, outer packaging or instructions for use if they carry the name and address of the natural or legal person who places them on the market in an EU or EEA state.

³ In vitro diagnostic medical devices that have been notified to the competent authority of an EU or EEA state in accordance with Article 6 paragraph 2 of the Medical Devices Ordinance of 17 October 2001 do not have to be additionally notified to Swissmedic.

Unless Swissmedic has designated common specifications in accordance with Article 8 paragraph 1 for devices without an intended medical purpose in accordance with Annex 1, these devices are subject to the old legislation.

¹ Conformity assessment body designations issued under Section 4 of the Medical Devices Ordinance of 17 October 2001¹⁰³ will become void.

² The conformity assessment body that issued the certificates under the old legislation will remain responsible for adequately monitoring these devices. It will be subject to supervision by Swissmedic.

³ Conformity assessment body designations issued under Section 4a of the Medical Devices Ordinance of 17 October 2001 will retain their validity.

⁴ Until a special Ordinance for in vitro diagnostic medical devices enters into force, the conformity assessment bodies for these devices will continue to be designated in accordance with Section 4 and 4a of the Medical Devices Ordinance of 17 October 2001.

¹ Until Article 17 paragraph 5 comes into force, the following reporting obligations will continue to apply to natural or legal persons domiciled in Switzerland:

a.

for manufacturers and natural or legal persons who assemble systems or procedure packs under Article 22 paragraphs 1 and 3 EU-MDR¹⁰⁵: the reporting obligations set out in Article 6 paragraphs 1 and 4 of the Medical Devices Ordinance of 17 October 2001¹⁰⁶:

b.

for natural or legal persons who place medical devices on the market under Article 2 paragraph 1 of the Medical Devices Ordinance of 17 October 2001: the reporting obligations set out in Article 6 paragraphs 3 and 4 of the Medical Devices Ordinance of 17 October 2001.

² ...¹⁰⁷

¹ Subject to the exceptions in paragraph 2, this Ordinance comes into force on 26 May 2021.

² Articles 17 paragraph 5 and 108 paragraph 2 will come into force at a later date.¹⁰⁹