Shape’s CE mark under the EU MDR encompasses its Impede and Impede-FX embolisation plugs and Impede RapidFill delivery ...

This week in Pedersen's POV, our senior editor finds humor in the European Commmission's plan to simplify the EU Medical ...

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...

Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

The course offers market opportunities by addressing the need for understanding and implementing the role of the Person Responsible for Regulatory Compliance (PRRC) under MDR and IVDR, critical for ...

Qase3D introduces MDR system form hospital 3D labs - a practical, legally grounded path to MDR compliance for Point-of-Care manufacturing.

Traditionally, if medical device manufacturers wanted to get products into a major market quick, they obtained CE Marking in the European Union first. The EU required proof of safety and performance, ...