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Medical Devices - Sector - Latest updates (147)
RSSMDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022
MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
MDCG 2022-20 - Substantial modification of performance study under Regulation (EU) 2017/746 - December 2022
MDCG 2022-19 - Performance study application/notification documents under Regulation (EU) 2017/746 - December 2022
MDCG 2022-18 - MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - December 2022
MDCG 2022-17 - MDCG position paper on ‘hybrid audits’ - December 2022
Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745
Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745
Updated information pack for candidate EU reference laboratories published
MDCG 2022-16 - Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - October 2022
MDCG 2019-6 Rev.4 - Questions and answers: Requirements relating to notified bodies (October 2022)
MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017 (September 2022)
MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD (September 2022)
MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs
MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies
Call for EU reference laboratories sent to Member States
MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)
Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements