Commission Implementing Regulation (EU) 2023/1194 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

The act is applicable from today and has been published on the Official Journal of the European Union.

2023-06-22T10:26:58+01:00

NBCG-Med webpage

The Commission published the « Template notified body confirmation letter » on the Public Health - Medical Devices web page. For more info, see following link: https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en

2023-05-25T10:05:32+01:00

Guidance on significant changes

The revision 1 of the MDCG 2020-3 regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD May 2023 and taking into consideration Regulation 2023/607 has been published. More info: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en  

2023-05-15T13:02:39+01:00
Go to Top