Posted By: Stephanie Bouzounis, Senior Communications Specialist
The European Union (EU) published a new Medical Device Regulation in May 2017, giving manufacturers three years before full implementation in 2020. There are several changes in this new regulation.
In a whitepaper by BSI titled, “Planning for implementation of the European Union Medical Devices Regulation – Are you prepared?”, MDR changes are discussed involving the upcoming implementation. One of the changes will be that products that were previously regulated under the directive as accessories are now considered devices. This would include products that were used to sterilize devices. Products used for aesthetics and cosmetics can now be considered medical devices, pending a benefit versus risk analysis. Product scope expansion in the MDR will include devices designed for the prediction and prognosis of a disease or health condition.
A big change that will occur involves an increase in classification. Class III devices will have higher clinical requirements and be scrutinized regularly. Surgical meshes, most devices in contact with the spinal column, and certain substance-based devices are examples of devices that will be up-classified. Another big change will be the increase in oversight by the Notified Bodies for Class IIb implants and Class I reusable surgical instruments. Notified Bodies will also be able to perform unannounced audits, product sample checks, and product testing. Manufacturers may be required to perform annual safety reporting.
For those familiar with the In-Vitro Device Regulation (IVDR) that was also recently issued, there are some parallels with the EU MDR. One of these areas concerns the oversight of medical device manufacturers and their marketed devices, especially when it comes to Post Market Surveillance (PMS). MDR Annex III and IVDR Annex II address technical documentation on post-market surveillance, with both requiring technical documentation to be a part of the Quality Management System (QMS). Manufacturers will also be required to designate and identify a person with the company to be responsible for compliance.
The MDR will mandate the use of unique device identification (UDI). This is to ensure the traceability of devices through the supply chain and to facilitate timely recalls if necessary. Rigorous clinical evidence for Class III devices and implantables will be required, and manufacturers will need to collect post-market clinical data as part of the ongoing assessment of clinical risk. For Class II devices, manufacturers will need to re-prepare their clinical evaluations.
The MDR that was issued can be found here. The key to staying abreast of these changes is to follow updates by reputable sources and to start preparing now. The new MDR is complex and if there is any assistance needed, medical device companies need to call EMMA International to help.
Have a question that did not get answered here? Call us at (248) 987-4497 or email info@emmainternational.com. For more information about international regulations and other related topics, check out these blogs:
- MDSAP – Don’t Let The World See Your Dirty Laundry
- MDSAP – What Manufacturers Need to Know
- Going Abroad? International Registrations for Medical Devices
