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Division 2.3 Increase of the overall TSE risk

United Kingdom

Original text. Later amendments are not shown.

Where on the basis of information submitted in accordance with section 2.1 or 2.2 F1an approved body establishes that the overall TSE risk in relation to a medical device is increased, F2this approved body shall follow the procedure set out in Article 5.

Annotations

Textual amendments

F1

Words in Annex 1 s. 2.3 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(f)(i)

F2

Words in Annex 1 s. 2.3 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(f)(ii)

Notes on Division 2

Textual amendments

F1

Annex 1 Section 2 heading substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(c)(i)

F2

Words in Annex 1 s. 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(c)(ii)