Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)

Introductory Text
Article 1.Definitions
Article 1a.In this Regulation, any reference to Annex 8 to Directive...
Article 2.Interpretation of designation criteria
Article 3.Procedure for the designation of approved bodies
Article 4.Extension and renewal of designation
Article 5.Surveillance and monitoring
Article 6.Investigation of the competence of an approved body
Article 7.Exchange of experience on designation and supervision of conformity assessment bodies
Article 8.Operating of designating authorities
Article 9.Cooperation with accreditation bodies
Article 10.Entry into force and date of application
Signature
1. ANNEX I
  Interpretation of the criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC
2. ANNEX II
  Application form to be submitted when applying for designation as an approved body

Commission Implementing Regulation (EU) No 920/2013Show full title