The EU’s Medical Device Regulation (MDR, effective May 26, 2021) and the In Vitro Diagnostics Regulation (IVDR, effective in May 2022) are certainly hurdles for medical device manufacturers to tackle. However, those aren’t the only new regulations in Europe to prepare for.
This collection of articles begins with lessons learned regarding economic operator responsibilities, overall quality management system considerations, and common challenges during EU MDR and EU IVDR implementation to ensure a smooth transition and avoid pitfalls during implementation. The second article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies. The e-book then moves on to examine the role of the contract manufacturer under both the MDR and IVDR before explaining how to navigate the MDR’s clinical data requirements.
Since Brexit was finalized on January 1, 2021 — due to the pandemic’s odd nature of lengthening our view of time, January seems so long ago, doesn’t it? — all medical devices must be registered with the Medicines and Healthcare products Regulatory Agency. The next article in this eBook provides 10 actions to prepare for the UK’s conformity assessment.
The e-book wraps up with a thorough exploration of the 2020 guide on digital health application requirements from Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, or the Federal Institute for Drugs and Medical Devices). You’ll need to follow these requirements in order to make your digital health applications available to the more than 73 million participants in the German statutory health insurance. Other nations will likely follow in Germany’s footsteps, so it’s best to get ahead of these requirements when you can.