Medical Devices - New regulations - Latest updates

Template for notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of Reg EU 2024/1860

Information session on MDR/IVDR for international regulators – 4 July 2024

Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices

Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices

Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)

Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR

MDR and IVDR Communication Survey

Updated - Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices

Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate

New Commission Implementing Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose (Annex XVI)

UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023

IMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods

Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions

Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension

Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023

Updated information pack for candidate EU reference laboratories published

Call for EU reference laboratories sent to Member States