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Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance) (repealed) in England

EU Directive 2003/32 · Adopted 23 April 2003 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Directive 2003/32/EC

of 23 April 2003

introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin

(Text with EEA relevance) (repealed)

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Annotations to the whole text

Textual amendments

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Repealed by Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives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).

Contents

  1. 1Article 1 Repealed
  2. 2Article 2 Repealed
  3. 3Article 3 Repealed
  4. 4Article 4 Repealed
  5. 5Article 5 Repealed
  6. 6Article 6 Repealed
  7. 7Article 7 Repealed
  8. 8Article 8 Repealed
  9. 9Article 9 Repealed
  10. 10Article 10 Repealed
  11. Annex Repealed
  12. RISK ANALYSIS AND RISK MANAGEMENT Repealed
  13. 1.1Justification for the use of animal tissues or derivatives Repealed
  14. 1.2Assessment procedure Repealed
  15. 1.2.1Animals as a source of material Repealed
  16. 1.2.2Geographical sourcing Repealed
  17. 1.2.3Nature of starting tissue Repealed
  18. 1.2.3.1Sheep and goats Repealed
  19. 1.2.3.2Cattle Repealed
  20. Inactivation or removal of transmissible agents Repealed
  21. 1.2.4.1Division 1.2.4.1 Repealed
  22. 1.2.4.2Division 1.2.4.2 Repealed
  23. 1.2.5Quantities of animal starting tissues or derivatives required to produce one unit of the medical device Repealed
  24. 1.2.6Tissues or derivatives of animal origin coming into contact with the patients and users Repealed
  25. 1.2.7Route of administration Repealed
  26. 1.3Review of the assessment Repealed
  27. 2EVALUATION OF CLASS III MEDICAL DEVICES BY NOTIFIED BODIES Repealed

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1.1Justification for the use of animal tissues or derivativesF1

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1.2Assessment procedureF1

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1.2.1Animals as a source of materialF1

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1.2.2Geographical sourcingF1

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1.2.3Nature of starting tissueF1

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1.2.3.1Sheep and goatsF1

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1.2.3.2CattleF1

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1.2.4.1F1

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1.2.4.2F1

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1.2.5Quantities of animal starting tissues or derivatives required to produce one unit of the medical deviceF1

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1.2.6Tissues or derivatives of animal origin coming into contact with the patients and usersF1

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1.2.7Route of administrationF1

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1.3Review of the assessmentF1

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2EVALUATION OF CLASS III MEDICAL DEVICES BY NOTIFIED BODIESF1

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