After a year delay due to the global pandemic, the European Medical Device Regulation (EU MDR) is now fully applicable to all devices. As of May 26, 2021, all medical device manufacturers that sell their products in Europe must comply with the new and expanded regulations, which replace the Medical Devices Directive (MDD).
Despite the delay, however, some organizations still don't feel confident that they have done what's needed to be in compliance. And for many, the tasks required to comply with the EU MDR have turned out to be more complex and time-consuming than they had anticipated.
One key change that's creating more work for organizations is the vastly expanded requirements for clinical data, which now extends oversight beyond the pre-market phase of device manufacturing to encompass a device’s entire lifespan, including post-market surveillance. To meet EU MDR requirements, device manufacturers must now produce both pre-market and post-market documentation and reports, including:
Another noteworthy change in EU MDR is that each organization must assign at least one person to be formally responsible for ensuring compliance. Article 15 of the EU MDR details the designee's responsibilities and requisite qualifications.
At Research Solutions, we know that adhering to the more rigorous clinical data and documentation requirements may be adding extra work and creating new challenges for medical device manufacturers. If you’re looking for ways to simplify your compliance strategies, we invite you to download our complimentary guide. It provides a quick recap of EU MDR’s key changes and offers tips to help you catch up and comply. Download the guide here: European Medical Device Regulation - What Is Included and How to Comply.