If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years for devices and five years for in vitro diagnostics — but for good reason.
The changes will affect every aspect of the development and regulatory acceptance of these products, as we discuss in our latest Premier Voices podcast with Janet Kube, Director of Project Management. And failure to comply with the deadlines of May 2020 and May 2022, respectively, could result in your products being removed from the EU market.
A few of the changes you need to plan for:
- Stricter requirements for comparative evaluation will make it much harder to demonstrate product safety and performance using equivalence data. The new rules require sponsors to generate more data on their devices, and that data will be subject to more rigorous interpretation. Thus, it will be more important than ever to collect sufficient clinical evidence to satisfy compliance and safety requirements.
- Additionally, a manufacturer performing a comparative evaluation will have to obtain agreement from the company whose device is used as the basis of the comparison, complicating and perhaps delaying the process.
- Notified bodies, the organizations accredited by EU member states to assess products for market approval, will need to be recertified and redesignated under the new rules. They also will face more stringent oversight by national authorities. The number of these entities already has fallen due to more stringent accreditation requirements, leaving only a few dozen overburdened Notified Bodies in existence today. That number is likely to fall further, causing evaluations to take longer and cost more.
- Another change, in keeping with the new provisions’ greater emphasis on regulatory and scientific rigor, will eliminate a longstanding provision that requires only a critical evaluation of published literature for approval of new products that are functionally similar to existing ones.
Check out our podcast, because it’s a complex subject — and it’s vital that device and diagnostics companies understand and plan for the upcoming changes.
Full presentation: https://youtu.be/opBqOrK_v3w
Additional resources: https://premierresearch.cn/tag/mdr/