December News
As we draw 2023 to a close, we can reflect on the year gone by and look forward to a new year. What can we expect to see in 2024 from a Medical Device and IVD Regulatory perspective?
The EU deadline for ensuring Manufacturers that place CE mark certified Medical Devices on the market that have not yet transitioned to the EU MDR 2017/745 have in place a contract with an EU approved Notified Body for recertification – May 2024
We are hoping to see draft regulation from the UK government on what the new UK medical device regulations will involve, which is expected to be in place by 2025.
EU MDCG Guidance Updates in December 2023
The Following New or Updated MDCG guidance documents were issued in December 2023:
MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products
MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products
MDCG 2021-6 Rev.1 – Regulation 2017/745 – Questions and Answers regarding clinical investigation
If you sell medical devices on the EU market you should check to ensure that you are following the latest guidance issued by the EU commission, MDCG documents can be found here.
Medical Device Standards Updated in December 2023
Medical Device Standards issued or updated in December 2023
