Europe – EMA establishes regular procedure for scientific advice on certain high-risk medical devices
EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their...
USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen...
International – IMDRF finalizes good machine learning practice, software risk documents
The International Medical Device Regulators Forum (IMDRF) on Wednesday finalized two highly anticipated technical documents detailing guiding principles for good machine learning practices (GMLP)...
Europe – Règlement D’exécution (UE) 2025/117 de la Commission du 24 janvier 2025
LA COMMISSION EUROPÉENNE,
vu le traité sur le fonctionnement de l’Union européenne,
vu le règlement (UE) 2021/2282 du Parlement européen et du Conseil du 15 décembre...
Europe – Revised versions and new guidance are available in the EMDN section
MDCG 2025-1 EMDN Ad hoc procedure January 2025
MDCG 2025-2 Summary of EMDN 2024 Submissions and outcome of annual revision January 2025
MDCG 2025-3 EMDN Version...
UK – MHRA guidance on new Medical Devices Post-Market Surveillance requirements
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance is designed to help medical device manufacturers...
UK – Implementation of medical devices future regime
The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices they need and...
USA – FDA finalizes guidance on reporting medical device shortages
The US Food and Drug Administration (FDA) issued finalized guidance on its requirements for notifying the agency of potential medical device shortages during or...
Europe – MDCG 2024-8 Rev. 1 Preliminary assessment review template – ...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDCG 2024-7 Rev. 1 Preliminary assessment review template – MDR...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
