MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Revision One MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Revision... MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – Revision One
Extended Producer Responsibility for Packaging Guidance Defra and EA have published guidance's on EPR. Extended Producer Responsibility for Packaging Guidance
Artificial Intelligence Act, a Provisional Agreement on Harmonized Rules on AI Artificial Intelligence Act, a Provisional Agreement on Harmonized Rules on AI The Council presidency and the European Parliament’s negotiators have... Artificial Intelligence Act, a Provisional Agreement on Harmonized Rules on AI
Team NB Publication – Position Paper – Medical Device Lifetime Team NB Publication – Position Paper – Medical Device Lifetime Team NB has published a position paper on Medical Device Lifetime. Team NB Publication – Position Paper – Medical Device Lifetime
MDCG Annex XVI Guidance Documents on Clinical Evidence & Qualification/Classification Published MDCG Annex XVI Guidance Documents on Clinical Evidence & Qualification/Classification Published The Commission has published the following MDCG Guidance documents... MDCG Annex XVI Guidance Documents on Clinical Evidence & Qualification/Classification Published
Planned Meetings of MDCG and Subgroups in 2024 Published Planned Meetings of MDCG and Subgroups in 2024 Published The European Commission has published the planned meeting dates of the... Planned Meetings of MDCG and Subgroups in 2024 Published
MHRA Guidance Update – Register Medical Devices to Place on the Market MHRA Guidance Update – Register Medical Devices to Place on the Market MHRA has updated the guidance on registering medical... MHRA Guidance Update – Register Medical Devices to Place on the Market
42nd Notified Body Has Been Designated Under the EU MDR 42nd Notified Body Has Been Designated Under the EU MDR Netherlands based notified body ‘Scarlet NB B.V.’ has been notified... 42nd Notified Body Has Been Designated Under the EU MDR
53rd CAMD Meeting Statement Published 53rd CAMD Meeting Statement Published The summary note of the 53rd Competent Authorities for Medical Devices (CAMD) plenary meeting... 53rd CAMD Meeting Statement Published
MDCG Position Paper – Notice to Manufacturers & NBs to Ensure Timely Compliance with MDR/IVDR Requirements Published MDCG Position Paper – Notice to Manufacturers & NBs to Ensure Timely Compliance with MDR/IVDR Requirements Published The Commission has... MDCG Position Paper – Notice to Manufacturers & NBs to Ensure Timely Compliance with MDR/IVDR Requirements Published
MHRA Board Terms of Reference Updated MHRA Board Terms of Reference Updated The MHRA has published an updated Terms of Reference for the MHRA Board on their... MHRA Board Terms of Reference Updated
Updated Carbon Reduction Plan and Net Zero Commitment Requirements Published Updated Carbon Reduction Plan and Net Zero Commitment Requirements Published Updated guidance on the application of Carbon Reduction Plans (CRPs)... Updated Carbon Reduction Plan and Net Zero Commitment Requirements Published