USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’...
Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for...
Europe – Règlement d’exécution (UE) 2023/1194 de la Commission du 20 juin 2023 modifiant...
Est paru le 21 juin 2023 au Journal Officiel de l’Union Européenne le Règlement d’exécution (UE) 2023/1194 modifiant les dispositions transitoires établies dans le Règlement...
UK – MHRA announces a proposed framework for international recognition of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) published a statement of policy intent for international recognition of medical devices.
The MHRA’s...
Europe – The designation of notified bodies under the upcoming Artificial Intelligence Act
Artificial Intelligence (AI) algorithms, in its various forms, machine learning, deep learning, etc., implemented as embedded software (SW) or standalone SW, are gaining in...
USA – FDA finalizes guidance allowing some contact lens sponsors 510(k) predicate leeway
The US Food and Drug Administration has finalized a guidance that allows some manufacturers to submit 510(k) applications for soft contact lenses based on...
Japan – Japan updates guidance on QMS Conformity Survey applications
Japan’s Ministry of Health, Labour and Welfare (MHLW) has updated its guidance on documents that medical device market registrants must submit when applying for...
France – Règlement européen relatif aux dispositifs médicaux : fin de la période de...
Le règlement UE 2017/745 relatif aux dispositifs médicaux, en vigueur depuis le 26 mai 2017, a été suivi d’un règlement modificatif UE 2023/607 en mars...
USA – Medical Device Development Tools (MDDT)
The FDA is announcing the qualification of a new tool through the Medical Device Development Tools (MDDT) program, marking the first-ever qualified database under...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
Europe – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607...
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional
provisions for certain...
