Europe – Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device...
Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002...
UK – Register medical devices to place on the market
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in...
France – Études en vie réelle – Recensement des sources de données mobilisables pour...
Les données en vie réelle ont pris une place majeure dans l’évaluation des produits de santé contribuant aux avis de la HAS tout au...
USA – FDA drafts guidance on device production and quality system software assurance
The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical...
France – Laurence Comte-Arassus élue présidente du Snitem
L’assemblée générale ordinaire du Snitem (Syndicat national de l’industrie des technologies médicales) s’est tenue le mardi 27 juin 2023 à la Chambre de commerce...
USA – Best Practices for Selecting a Predicate Device to Support a Premarket Notification...
FDA developed this document to provide guidance to industry and FDA staff about best practices in selecting a predicate device for premarket notification ...
UK – NICE recommends AI technologies for radiotherapy treatment planning
The recommendation aims to speed up the time taken to produce outlines of healthy organs, in order to help target cancer cells while avoiding...
International – FDA warns Philips about imaging device violations at China facility
The US Food and Drug Administration (FDA) has warned Philips about manufacturing violations at the company’s facility in Suzhou, China, where computed tomography (CT)...
UK – EM on EU regulations 2017/745 & 2017/746 (COM(2024)43)
This explanatory memorandum is about a European Commission for a proposal for a regulation of the European Parliament and of the Council amending regulations (EU)...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
