Standards
What are the harmonized standards applied to medical devices, the compliance to which will be evaluated in the Conformity Assessment process?
COUNCIL DIRECTIVE 93/42/EEC
(5 September 2007)
Article 5
Reference to standards
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 harmonized standards the references of which have been publishes in the Official Journal of the European Communities; Member States shall publish the references of such national standards.
2. For the purposes of this Directive, reference to harmonized standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and 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 Communities.
3. If a Member State or the Commission considers that the harmonized standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6 (2).
Article 6
Committee on Standards and Technical Regulations
1. The Commission shall be assisted by the Committee set up by Article 5 of Directive 98/34/EC, hereinafter referred to as ‘the Committee’.
2. Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. The Committee shall adopt its rules of procedure.
Article 7
1. The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC, hereinafter referred to as ‘the Committee’.
2. 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.
3. 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.
4. 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.