USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
Europe – User guide for micro, small and medium-sized enterprises
This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...
USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They...
Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according...
USA – FDA proposes guidance on orthopedic product coatings
The US Food and Drug Administration (FDA) wants orthopedic device sponsors to provide additional data in their premarket application if their product has a...
Europe – Commission proposes measures to improve the availability of in vitro diagnostics
Today, the European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. With this...
Europe – Regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and...
The Communication of the Commission of 11 December 2019 on ‘The European Green Deal’ (the ‘European Green Deal’) is Europe’s growth strategy that aims...
France – DTx : la réglementation se met progressivement en place
Les DTx (pour Digital Therapeutics) sont des dispositifs médicaux (DM) d’un nouveau genre qui entendent alléger, compléter voire remplacer la prise de médicaments. Leur...
Europe – Overview of language requirements for manufacturers of medical devices
The Commission and Member States have created MDR and IVDR tables.
These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and...
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...
UK – Implementation of medical devices future regime
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The...
