JD Supra

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...
JD Supra

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the ...
Medical Device and Diagnostic Industry (MD+DI)

Will Simplified EU MDR Come with Free Therapy?

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

HIV-specific factors contribute to increased risk for MDR-E

Please provide your email address to receive an email when new articles are posted on . You've successfully added to your alerts. You will receive an email when new content is published. Click Here to ...
Mason Hayes Curran

EU Commission Proposes Reform of the Medical and In Vitro Device Regulations

Following the identification of several key challenges in the application of the Medical Device Regulation (MDR) and In Vitro ...