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Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)

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Changes over time for: Division 4.

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4.Examination of the design of the productU.K.+E.U.

4.1.In addition to the obligations incumbent on him under section 3, the manufacturer shall make an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in 3.1.U.K.+E.U.

4.2. [F1The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).] U.K.+E.U.

It shall include inter alia:

  • the design specifications, including the standards which have been applied,

  • the necessary proof of their appropriations, in particular where the standards referred to in Article 5 have not been applied in full. This proof must include the results of the appropriate tests carried out by the manufacturer or carried out under his responsibility,

  • a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of Annex 1, whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted,

  • the clinical [F1evaluation] referred to in Annex 7,

  • the draft instruction leaflet.

4.3.The notified body shall examine the application and, where the product complies with the relevant provisions of this Directive, shall issue the applicant with an EC design examination certificate. The notified body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Directive may be evaluated. The certificate shall contain the conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.U.K.+E.U.

[F2In 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.]

4.4.The applicant shall inform the notified body which issued the EC design examination certificate of any modification made to the approved design. Modifications made to the approved design must obtain supplementary approval from the notified body which issued the EC design examination certificate where such modifications may affect conformity with the essential requirements of this Directive or the conditions prescribed for the use of the product. This supplementary approval shall be given in the form of an addendum to the EC design examination certificate.U.K.+E.U.

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