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 ...

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

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 ...

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

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 ...

Medical devicemakers in the European market are one step closer to securing a bit of breathing room after saying new regulatory laws could lead to product shortages among their businesses. The ...

Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...