Standards
What are the harmonized standards applied to medical devices, the compliance to which will be evaluated in the Conformity Assessment process?
Council Directive 90/385/EEC
(5 September 2007)
Article 5
1. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union; Member States shall publish the references of such national standards.
2. For the purposes of this Directive, reference to harmonised standards also includes the monographs of the European Pharmacopoeia notably on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Union.
Article 6
1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 do not entirely meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Directive 98/34/EC, giving the reasons therefor. The Committee shall deliver an opinion without delay.
In the light of the opinion of the Committee, the Commission shall inform Member States of the measures to be taken with regard to the standards and the publication referred to in Article 5.
2. The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).
3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.