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The Medical Devices (Amendment) Regulations 2008
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- UK Statutory Instruments
- 2008 No. 2936
- Regulation 7
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Amendment of regulation 14 of the principal Regulations
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7. In regulation 14 of the principal Regulations (procedures for systems and procedure packs, and for devices to be sterilised before use), in paragraph (4)—
(a)for sub-paragraph (a), substitute—
“(a)follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; and”; and
(b)after paragraph (4) insert—
“(4A) The application of Annex II or IV and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.”.
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