Understanding the MDR & IVDR: What Medical Device Companies Need to Know

October 1, 2019 By MassDevice Leave a Comment

By Brandy Chittester, MS, CCRA, President

These regulations are intended to place a greater emphasis on safety, with greater requirements for clinical evidence and increased oversight by regulatory agencies.

The regulations will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed to ensure compliance. This impacts every aspect of the organization, from research and development to manufacturing and marketing.

Medical device manufacturers will likely need additional clinical data to certify and re-certify devices, which could be gathered or generated from various sources and methods. They will also need to perform additional post-market surveillance to provide safety and effectiveness oversight for the lifecycle of a device. There are many understandable concerns about how this will impact device companies, and there are still many unknowns.

In this new resource, we’ll discuss the most important elements you need to know and how you can start preparing.

To navigate the complexities of this new change, companies are understandably turning to outside organizations for guidance and support, and organizations have released helpful resources to decipher the new requirements.

So what do companies need from their CRO to ensure a good fit for assisting with the MDR and IVDR transition work? Download this whitepaper for six characteristics that should be considered as a minimum set of requirements.

For device and IVD manufacturers, the negative consequences that are predicted from the European Union’s implementation of the new MDR and IVDR requirements in 2020 and 2022, respectively, have been widely publicized and appear daunting. IMARC recently hosted a webinar to explore some of the upcoming challenges, benefits and six essential “musts” – from a clinical research point of view – that should be in everyone’s MDR survival guide in order to successfully navigate the complexities inherent in this change.

We’ve been digging into the details so we can answer your most pressing questions. Watch the recorded webinar to learn more about what’s coming and get on the path to compliance. Or contact us today about your EU MDR strategy.

Sponsored content by IMARC

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