USA – FDA proposes down-classifying most high-risk IVDs
The US Food and Drug Administration (FDA) intends to reclassify most high-risk in-vitro diagnostics (IVDs) from class III devices to class II moderate-risk devices....
Europe – Experts outline challenges of combination products in Europe
Combination products are increasingly important, increasingly complex and are increasing the pressure on the European regulatory network, according to Thomas Wejs Møller, senior director...
Europe – MDCG endorsed documents and other guidance
MDCG a publié 5 nouveaux documents concernant les conseils de vigilance spécifiques aux dispositifs (DSVG). Le document initial est "MDCG 2024-1 Guidance on the...
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The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...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...
