Regulatory Affairs Professionals Society

Euro Roundup: MedTech Europe welcomes IVDR proposals, calls for strengthening of some changes

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many ...
RAPS

MDCG guidance clarifies permitted changes to devices launched ahead of IVDR

Manufacturers that bring devices to market ahead of the In Vitro Diagnostic Regulation (IVDR) have a clearer idea of the changes they can make to products thanks to new guidance. The IVDR is due to ...
MD&M East

EU Moves to Ease MDR/IVDR Compliance with Risk-Based Changes

After a shove from European Parliament, EU member states, and industry stakeholders, the European Commission (EC) issued proposed amendments to streamline its medical device and in vitro diagnostic ...
MarketWatch

EU (European Union) and UK Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) Update Training Course (Online Event: April 29, 2026 ...

The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...
JD Supra

Medical devices: EU Commission proposes MDR and IVDR revision

The EU Commission published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) on December 16, 2025.
Fieldfisher

New pre-market requirements for medical devices – what's changed?

Fieldfisher had previously outlined the likely direction of Great Britain’s new pre-market medical device regime based on consultation materials and MHRA policy statements (see ...