The new Medical Device Regulation (MDR) is soon to come into effect, so it is important that medical device manufacturers within Europe are prepared.
What is the Medical Device Regulation (MDR)?
From the 26th May 2020, the MDR will replace the EU’s current Medical Device Directive (MDD). After decades of the MDD being in place, this introduction of new regulatory framework is one of the most significant changes to be made. It is going to alter the rules for operating processes, including selling and marketing, for global medical device companies or any that sell trade in Europe.
What Are the MDR Requirements?
Here is a general overview of some of the major requirements declared by the MDR:
Medical Product Range Expansion
Medical device and active implantable medical device categories will be expanded under the MDR. These will include some devices that do not have a medical intended purpose, like coloured contact lenses and cosmetic implant materials, and prediction and prognosis devices.
Unique Device Identification (UDI)
The MDR requires the use of UDI instruments in order to increase the ability for manufacturers to identify specific devices throughout the supply chain. This is especially required in case of the recall of medical devices due to a safety risk, as this is expected to ensure a prompt and efficient withdrawal.
Clinical Data Management
Risk management, post-market surveillance, clinical evaluation and clinical studies all need to be closely aligned and documented throughout the device lifecycle under the MDR. This clinical evidence is fundamental to the safety of every Class III device and both manufacturers and distributors will have to maintain this documentation in permanent compliance.
As the transition date is quickly approaching, it is a smart move to start preparing so you can gradually migrate and get comfortable with the new regulation.
Full Portfolio Review
Regarding the clinical data management, it is a good idea for manufacturers to assess their entire portfolio to make sure that every piece of documentation has been completed. Any gaps that have been identified can then be filled before the MDR is put into place.
Allotting Time and Resources
Thinking about the future, and the additional procedures companies are going to have to follow under the MDR, new ongoing compliance processes will have to be implemented now in order to comprehend the degree of change. Once you start putting the time and resources aside, you can get used to the new regime before May 2020.
Don’t panic, you still have time to prepare but remember not to leave it too late. For more information about the new European Medical Device Regulation, visit gov.uk website.