JD Supra

MDD Certificates Remain Valid: European Commission Proposes Longer Transition Periods for MDR Compliance

On Friday, January 6, 2023, the European Commission adopted a proposal to give more time to certify medical devices in hopes of mitigating the risk of shortages in the European Union (EU). The ...
JD Supra

European Commission proposes to extend MDR transition periods to prevent shortages in medical devices

The European Commissioner for Health and Food Safety, Stella Kyriakides, has proposed measures to extend the transition rules of Medical Device Regulation (EU) 2017/745 (MDR) at the Employment, Social ...
MD&M East

Understanding the EU MDR

In a recent MD+DI webinar called, “Understanding the EU MDR”, which was sponsored by Accumold, Nelson Laboratories, and Oliver Healthcare Packaging, Dr. Bassil Akra, CEO of Akra Team GmbH, gave ...
HealthTech

MDR Medical Device Regulations: A Safety Net or Too Much Restriction?

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.
TCTMD

European Transition from Medical Device Director (MDD) to Medical Device Regulation (MDR): Roadmap for the Future of Global AF Studies

Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...