1. The person first placing a device on the market is responsible for the conformity assessment procedure and for the preparation of the declaration of conformity. The definitions and procedures to be used are found:
- a.
- for active implantable medical devices, in Annexes 2-5 of Directive 90/385/EEC122;
- b.
- for classical medical devices, in Annexes II-X of Directive 93/42/EEC123;
- c.
- for in vitro diagnostic medical devices, in Annexes II-VIII of Directive 98/79/EC124.
2. A conformity assessment body is used:
- a.
- for active implantable medical devices as laid down in Directive 90/385/EEC;
- b.
- for classical medical devices in Class IIa, IIb and III as laid down in Directive 93/42/EEC;
- c.
- for in vitro diagnostic medical devices for self-testing;
- cbis.
- for in vitro diagnostic medical devices as laid down in Annex II of Directive 98/79/EC, even if manufactured in house (except for products in accordance with Section 3, letter b);
- d.
- for classical medical devices in Class I which are sterilised or have a measuring function.
3. A conformity assessment body need not be used for:
- a.
- the other classical medical devices in Class I (not sterile, not having a measuring function);
- b.
- in vitro diagnostic medical devices manufactured in house as laid down in Annex II of Directive 98/79/EC if:
- 1.
- the manufacturing company is a nationally designated reference laboratory or a laboratory with an equivalent qualification, and
- 2.
- no common technical specifications exist for the medical devices in question.
- bbis.
- the other in vitro diagnostic medical devices to which section 2 does not apply;
- c.
- all medical devices which are to be subjected to a clinical investigation or a performance evaluation;
- d.
- custom-made devices.
4. Any supplier who assembles a system or procedure pack must declare that:
- a.
- the mutual compatibility of the components in accordance with the instructions drawn up by the person who placed them on the market has been tested and is established;
- b.
- the system or procedure pack is accompanied by relevant user instructions, including those from the person who placed them on the market; and
- c.
- all activities are monitored internally in a suitable manner.
5. Conformity assessment for classical medical devices in Class I:
The conformity assessment shall be carried out as laid down in Annex VII of Directive 93/42/EEC. The required declaration of conformity shall be drawn up before placing the devices on the market for the first time.
6. Conformity assessment for classical medical devices in Class IIa:
The conformity assessment shall be carried out as laid down in one of the following procedures in accordance with Directive 93/42/EEC:
- a.
- the procedure for EC declaration of conformity in accordance with Annex VII of this Directive in conjunction with the procedure:
- 1.
- for EC verification in accordance with Annex IV,
- 2.
- for EC declaration of conformity (Production quality assurance) in accordance with Annex V,
- 3.
- for EC declaration of conformity (Product quality assurance) in accordance with Annex VI;
- b.
- the procedure for the full quality assurance system (EC declaration of conformity in accordance with Annex II of this Directive); in this case, Annex II, Section 4 does not apply.
The required declaration of conformity shall be drawn up before placing the devices on the market for the first time.
7. Conformity assessment for classical medical devices in Class IIb
The conformity assessment shall be carried out as laid down in one of the following procedures in accordance with Directive 93/42/EEC:
- a.
- the procedure for the full quality assurance system (EC declaration of conformity in accordance with Annex II of this Directive); in this case, Annex II, Section 4 does not apply;
- b.
- the procedure for the EC type-examination in accordance with Annex III of this Directive in conjunction with the procedure:
- 1.
- for EC verification in accordance with Annex IV,
- 2.
- for EC declaration of conformity (Production quality assurance) in accordance with Annex V, or
- 3.
- for EC declaration of conformity (Product quality assurance) in accordance with Annex VI.
The required declaration of conformity shall be drawn up before placing the devices on the market for the first time.
8. Conformity assessment for classical medical devices in Class III:
The conformity assessment shall be carried out as laid down in one of the following procedures in accordance with Directive 93/42/EEC:
- a.
- the procedure for the full quality assurance system (EC declaration of conformity in accordance with Annex II of this Directive);
- b.
- the procedure for the EC type-examination in accordance with Annex III of this Directive in conjunction with the procedure:
- 1.
- for EC verification in accordance with Annex IV,
- 2.
- for EC declaration of conformity in accordance with Annex V.
The required conformity declaration shall be drawn up before placing the devices on the market for the first time.
9. Conformity assessment for active implantable medical devices:
The conformity assessment shall be carried out as laid down in one of the following procedures in accordance with Directive 90/385/EEC:
- a.
- the procedure for the full quality assurance system (EC declaration of conformity in accordance with Annex 2 of this Directive).
- b.
- the procedure for the EC type-examination in accordance with Annex 3 of this Directive in conjunction with one of the following procedures:
- 1.
- for EC verification in accordance with Annex 4, or
- 2.
- for EC declaration of conformity in accordance with Annex 5.
The required conformity declaration shall be drawn up before placing the devices on the market for the first time.
10. Conformity assessment for custom-made devices and medical devices for clinical investigation in all classes:
The conformity assessment shall be carried out as laid down in Annex VIII of Directive 93/42/EEC or for active implantable medical devices as laid down in Annex 6 of Directive 90/385/EEC.
11. Conformity assessment for all in vitro diagnostic medical devices with the exception of those mentioned in Annex II of Directive 98/79/EC, those intended for self-testing and those intended for performance evaluation:
The conformity assessment shall be carried out as laid down in Annex III of Directive 98/79/EC. The required declaration of conformity shall be established before placing the devices on the market for the first time.
12. Conformity assessment for in vitro diagnostic medical devices for self-testing:
The conformity assessment shall be carried out as laid down in one of the following procedures:
- a.
- in accordance with Annex III of Directive 98/79/EC;
- b.
- in accordance with Section 13;
- c.
- in accordance with Section 14.
If the procedure is carried out as laid down in Annex III of Directive 98/79/EC, the development of the products in accordance with Section 6 of this Annex must be confirmed by a conformity assessment body with an EC design-examination certificate and the required declaration of conformity must be drawn up before placing the devices on the market for the first time.
13. Conformity assessment for in vitro diagnostic medical devices as laid down in Annex II, List B of Directive 98/79/EC:
The conformity assessment shall be carried out as laid down in one of the following procedures in accordance with Directive 98/79/EC:
- a.
- the procedure for the full quality assurance system (EC declaration of conformity in accordance with Annex IV of this Directive);
- b.
- the procedure for the EC type-examination in accordance with Annex V of this Directive in conjunction with one of the following procedures:
- 1.
- for EC verification in accordance with Annex VI, or
- 2.
- for EC declaration of conformity in accordance with Annex VII.
The required conformity declaration shall be drawn up before placing the devices on the market for the first time.
14. Conformity assessment for in vitro diagnostic medical devices as laid down in Annex II, List A of Directive 98/79/EC:
The conformity assessment shall be carried out as laid down in one of the following procedures in accordance with Directive 98/79/EC:
- a.
- the procedure for the full quality assurance system (EC declaration of conformity in accordance with Annex IV of this Directive);
- b.
- the procedure for the EC type-examination in accordance with Annex V of this Directive in conjunction with the procedure for production quality assurance in accordance with Annex VII.
The required conformity declaration shall be drawn up before placing the devices on the market for the first time.
15. Conformity assessment for in vitro diagnostic medical devices, for performance evaluation:
The conformity assessment shall be carried out as laid down in Annex VIII of Directive 98/79/EC. A statement as laid down in Annex VIII of Directive 98/79/EC shall be drawn up before the performance evaluation.
16. Conformity assessment for in vitro diagnostic medical devices manufactured in house:
A declaration must be drawn up for the product, which includes the following information:
- a.
- identification of the product;
- b.
- name and address of the manufacturing company;
- c.
- declaration that the product corresponds to the essential requirements.
The manufacturing company must have an appropriate quality assurance system as laid down in recognised national or international standards (e.g. good practice in microbiological and serological laboratories in accordance with the Ordinance of 26 June 1996125 on Microbiological and Serological Laboratories, European standard ISO/IEC 17025 2000 [General requirements for the competence of testing and calibration laboratories] or EA-04/10 2002 [Accreditation for Microbiological Laboratories]).
The documentation relating to the product must prove that the product corresponds to the essential requirements in accordance with Annex I of Directive 98/79/EC and to its claimed performance.
For medical devices in accordance with Annex II of Directive 98/79/EC, such a procedure may only be applied if:
- a.
- the manufacturing company is a nationally designated reference laboratory or a laboratory with an equivalent qualification;
- b.
- the product is classified as laid down in List A of this annex; and
- c.
- no common technical specifications exist for the medical devices in question.
17. Conformity assessment for the reprocessing of medical devices by third parties:
- a.
- A declaration must be drawn up for the product to be reprocessed, with the following information:
- 1.
- identification of the product,
- 2.
- name and address of the company carrying out the reprocessing,
- 3.
- declaration confirming that the product has been reprocessed as laid down in the instructions drawn up by the person who first placed it on the market, or declaration that a risk analysis and a validation procedure has provided proof that own reprocessing procedures are applied in an equally safe and effective manner.
- b.
- The company carrying out the reprocessing must have an appropriate quality assurance system as laid down in nationally or internationally recognised standards.
- c.
- The documentation relating to the reprocessing must prove that the product has been reprocessed in accordance with letter a number 3.