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

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)

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Commission Implementing Regulation (EU) No 920/2013 is up to date with all changes known to be in force on or before 01 July 2024. There are changes that may be brought into force at a future date. Help about Changes to Legislation

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Changes and effects yet to be applied to :

  1. Introductory Text

  2. Article 1.Definitions

  3. Article 1a.In this Regulation, any reference to Annex 8 to Directive...

  4. Article 2.Interpretation of designation criteria

  5. Article 3.Procedure for the designation of approved bodies

  6. Article 4.Extension and renewal of designation

  7. Article 5.Surveillance and monitoring

  8. Article 6.Investigation of the competence of an approved body

  9. Article 7.Exchange of experience on designation and supervision of conformity assessment bodies

  10. Article 8.Operating of designating authorities

  11. Article 9.Cooperation with accreditation bodies

  12. Article 10.Entry into force and date of application

  13. 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

      1. 1. Sections 1 and 5 of Annex 8 to Directive 90/385/EEC...

      2. 2. The second paragraph of Section 2 of Annex XI to...

      3. 3. Sections 3 and 4 of Annex 8 to Directive 90/385/EEC...

      4. 4. Sections 6 of Annex 8 to Directive 90/385/EEC and of...

      5. 5. Sections 7 of Annex 8 to Directive 90/385/EEC and of...

    2. ANNEX II

      Application form to be submitted when applying for designation as an approved body

      1. Designating authority: …

      2. Name of the applying conformity assessment body: …

      3. Previous name (if applicable): …

      4. Approved Body number (if applicable): …

      5. Address: …

      6. Contact person: …

      7. E-mail: …

      8. Telephone: …

      9. Legal form of the conformity assessment body: …

      10. Company registration number: …

      11. At company register: …

      12. The following documents shall be added. In case of extension...

      13. Item/issue Corresponding Annex I section Attachment number + Reference(Section/page) ORGANISATIONAL...

      14. Name and signature of an authorised representative of the applicant...

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