93 42 EEC Medical Device Directive
MDD Article 13 – Decisions with regard to classification and derogation clause
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A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:
A) that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;
B) that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;
C) that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;
D) that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).
The Commission shall inform the Member States of the measures taken.
Medical Device Validation, Regulation, Classification, Risk Evaluation, ….
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