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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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- Regulations originating from the EU
- 2012 No. 722
- ANNEX II
- Data relating to the...
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Changes over time for: Data relating to the (active implantable) medical device
Changes to legislation:
Commission Regulation (EU) No 722/2012, Data relating to the (active implantable) medical device is up to date with all changes known to be in force on or before 17 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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Changes and effects yet to be applied to Annex II Division 2:
- 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))
- Regulation applied by S.I. 2002/618, reg. 4K(3) (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))
- Regulation revoked by S.I. 2002/618, reg. 4K (as substituted) by S.I. 2021/873 Sch. 1 para. 4
Data relating to the (active implantable) medical deviceU.K.
11.
(a)
Active implantable medical device Other medical device
11.
(b)
Product description and composition
12.Information on intended useU.K.
13.Starting materialU.K.
13.
(a)
EDQM certificate available YES NO
(If the EDQM certificate is available, it must be submitted with this summary evaluation report.)
13.
(b)
Information regarding
the nature of the starting tissue(s):
animal species(s):
geographical source(s):
14.A description of the key elements adopted to minimise the risk of infection:U.K.
15.An estimate of the TSE risk arising from the use of the product, taking into account the likelihood of contamination of the product, the nature and duration of patient exposure:U.K.
16.A justification for the use of animal tissues or derivatives in the medical device, including a rationale for the acceptability of the overall TSE risk estimate, the evaluation of alternative materials and the expected clinical benefit:U.K.
17.The approach to the auditing of source establishments and suppliers for the animal material used by the device manufacturer:U.K.
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