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Commission Regulation (EU) No 722/2012Show full title

Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)

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  • Regulation applied by S.I. 2002/618, reg. 4K(2)(4) (as inserted) by S.I. 2019/791 reg. 3(7) (This amendment not applied to legislation.gov.uk. The affecting text in reg. 3(7) is omitted (31.12.2020 immediately before IP completion day) by virtue of S.I. 2020/1478, reg. 1(3), Sch. 2 para. 9(h))
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  • Regulation revoked by S.I. 2002/618, reg. 4K (as substituted) by S.I. 2021/873 Sch. 1 para. 4

  1. Introductory Text

  2. Article 1.(1) This Regulation lays down particular requirements in relation to...

  3. Article 2.For the purposes of this Regulation, the following definitions apply...

  4. Article 3.(1) Before lodging an application for a conformity assessment for...

  5. Article 4.(1) The Secretary of State must verify on a regular...

  6. Article 5.(1) Conformity assessment procedures for medical devices referred to in...

  7. Article 6.Without prejudice to Article 7(2), Member States shall take all...

  8. Article 7.(1) Holders of EC design-examination certificates or EC type-examination certificates...

  9. Article 8.Directive 2003/32/EC is repealed with effect from 29 August 2013....

  10. Article 9.This Regulation enters into force on the twentieth day following...

  11. Signature

    1. ANNEX I

      1. 1. RISK ANALYSIS AND RISK MANAGEMENT

        1. 1.1. Justification for the use of animal tissues or derivatives

        2. 1.2. Process of risk assessment

          1. 1.2.1. Animals as a source of material

          2. 1.2.2. Geographical sourcing

          3. 1.2.3. Nature of starting tissue

          4. 1.2.4. Slaughtering and processing controls to prevent cross contamination

          5. 1.2.5. Inactivation or removal of TSE infectious agents

            1. 1.2.5.1. For devices which cannot withstand an inactivation or elimination process...

            2. 1.2.5.2. For other devices, if claims are made by the manufacturer...

          6. 1.2.6. Quantities of animal tissues or derivatives required to produce one...

          7. 1.2.7. Tissues or derivatives of animal origin coming into contact with...

          8. 1.2.8. Route of administration

        3. 1.3. Review of the risk assessment

      2. 2. EVALUATION BY APPROVED BODIES

        1. 2.1. Information of the Approved Body regarding changes and new information...

        2. 2.2. Renewal of certificates

        3. 2.3. Increase of the overall TSE risk

      3. 3. RIGOROUS PROCESSES FOR TALLOW DERIVATIVES AS REFERRED TO IN ARTICLE...

    2. ANNEX II

      Details relating to the submitting approved body

      1. Details relating to the submitting notified body

        1. 1. Name of approved body

        2. 2. Approved body number

        3. 3. Country

        4. 4. Sent by

        5. 5. Contact person

        6. 6. Telephone

        7. 7. Fax

        8. 8. E-mail

        9. 9. Client reference (name of manufacturer and, if applicable, of authorised...

        10. 10. Confirmation that the submitting approved body has been designated by...

      2. Data relating to the (active implantable) medical device

        1. 11.  Active implantable medical device  Other medical device

        2. 11. Product description and composition

        3. 12. Information on intended use

        4. 13. Starting material

          1. 13. EDQM certificate available  YES  NO (If the EDQM...

          2. 13. Information regarding the nature of the starting tissue(s): animal species(s):...

        5. 14. A description of the key elements adopted to minimise the...

        6. 15. An estimate of the TSE risk arising from the use...

        7. 16. A justification for the use of animal tissues or derivatives...

        8. 17. The approach to the auditing of source establishments and suppliers...

      3. Approved Body Statement

        1. 18. Conclusion of this assessment:

      4. Date of submission

        1. 19. This report was sent on … to the Coordinating Competent...

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