Council Directive 90/385/EEC
(5 September 2007)
ANNEX 3
EC TYPE EXAMINATION
1. EC type-examination is the procedure whereby a notified body observes and certifies that a representative sample of the production envisaged satisfies the relevant provisions of this Directive.
2. The application for EC type-examination shall be made by the manufacturer, or by his authorized representative established in the Community, to a notified body.
The application shall include:
- the name and address of the manufacturer and the name and address of the authorized representative if the application is made by the latter,
- a written declaration specifying that an application has not been made to any other notified body,
- the documentation described in section 3 needed to allow an evaluation to be made of the conformity of a representative sample of the production in question, hereinafter referred to as ‘type’, with the requirements of this Directive.
The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary.
3. The documentation must make it possible to understand the design, the manufacture and the performances of the product. The documentation shall contain the following items in particular:
- a general description of the type, including any variants planned, and its intended use(s),
- design drawings, methods of manufacture envisaged, in particular as regards sterilization, and diagrams of parts, sub-assemblies, circuits, etc.,
- the descriptions and explanations necessary for the understanding of the abovementioned drawings and diagrams and of the operation of the product,
- a list of the standards referred to in Article 5, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards referred to in Article 5 have not been applied,
- the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
- a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
- the pre-clinical evaluation,
- the clinical evaluation referred to in Annex 7,
- the draft instruction leaflet.
4. The notified body shall:
4.1. examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in Article 5, as well as the items for which the design is not based on the relevant provisions of the said standards;
4.2. carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of this Directive where the standards referred to in Article 5 have not been applied;
4.3. carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;
4.4. agree with the applicant on the place where the necessary inspections and tests will be carried out.
5. Where the type meets the provisions of this Directive, the notified body shall issue an EC type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved.
The significant parts of the documentation shall be attached to the certificate and a copy shall be kept by the notified body.
In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned.
In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.
6. The applicant shall inform the notified body which issued the EC type-examination certificate of any modification made to the approved product.
Modifications to the approved product must receive further approval from the notified body which issued the EC type-examination certificate where such modifications may affect conformity with the essential requirements or with the conditions of use specified for the product. This new approval shall be issued, where appropriate, in the form of a supplement to the initial EC type-examination certificate.
7.Administrative provisions
7.1. On request, each notified body shall make available to the other notified bodies and the competent authority, all relevant information on EC type-examination certificates and addenda issued, refused or withdrawn.
7.2. Other notified bodies may obtain a copy of the EC type-examination certificates and/or the addenda to them. The annexes to the certificates shall be made available to the other notified bodies when a reasoned application is made and after the manufacturer has been informed.
7.3. The manufacturer or his authorized representative shall keep with the technical documentation a copy of the EC type-examination certificates and the supplements to them for a period of at least 15 years from the manufacture of the last product.