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15 June 2020

VIGILANCE forms and annexes - May 2020 releases

May 01, 2020 - Changes in Manufacturer Incident Reporting
MIR rev. 7.2.1 release.
January 2020 "Help Text" (list of Annexes A to F codes) is still applicable,
but Annex G (components) has also been released from IMDRF website last May.
15 June 2020

MDCG Guidances releases

Latest releases - MDCG Guidances from DOC ROOM EUROPE
27 May 2020

May 19, 2020 - Official Journal of the European Union

Official Journal of the European Union 2020 | C 171 | 1 May 19, 2020
COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 (2020/C 171/01)
8 May 2020

Mid April 2020 - MDCG Guidances release

April 15 - MDCG Guidances
21 January 2020

MIR 7.2 and its A to F completed annexes

2020-January VIGILANCE _ MIR 7.2 and its A-to-F complete annexes

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30 July

2024-07-24 New Annexes A to G for MIR Form updated 9 May 2024

2024-07-24 New Annexes A to G for MIR Form updated 9 May 2024Link: (...)
24 January

2024-01-23: Proposal from the European Commission for IVDR extension of the transitional period & MDR-IVDR new shorter mandatory dates for EUDAMED

The European Commission today, (January 23, 2024) published a proposal (See attached the proposal, press release, Q&A).
21 December 2023

EU: REACH - ANNEX XVII RESTRICTION ON MICROPLASTICS WAS PUBLISHED ON SEPTEMBER 27, 2023

WHAT ARE THE IMPACTS FOR IVDs and MDs ?
7 December 2023

Regulation (EU) 2023/2713 of 5 December 2023 designating the European Union reference laboratories

The European Commission yesterday published Commission Implementing (...)
1 August 2023

The new transitional deadlines for medical devices

REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

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