# 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), Article 9a

Extent: E+W+S+N.I.

1. A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:
that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,
that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).
Where measures are deemed necessary pursuant to the first subparagraph of this paragraph they shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).
2. The Commission shall inform the Member States of the measures taken.

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Source: https://www.legislation.gov.uk/eudr/1990/385/article/9a (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/article-9a
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.