Division 2 EVALUATION BY APPROVED BODIESF1
United Kingdom
For the medical devices referred to in Article 1(1), manufacturers must provide to the F2approved bodies referred to in Article 4 all relevant information to allow evaluation of their risk analysis and risk management strategy in accordance with Article 5(2).
- 2.1Information of the Approved Body regarding changes and new information
- 2.2Renewal of certificates
- 2.3Increase of the overall TSE risk
Annotations
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)