The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with MDR.
Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.
In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles.
One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
Gain insight into the notified body approach to assessing biological equivalence and how manufacturers can make sure their equivalence justifications pass notified body review.
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.
The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal of clarifying the requirements for market actors and protecting EU patients.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
