IMPORTANT NOTE: In order to concentrate all capacities on combating the corona virus, the EU Commission has postponed the EU Medical Device Regulation (MDR) to May 26, 2021.
The upcoming 2021 deadline for compliance with the EU MDR presents a huge challenge for medical device manufacturers. Here’s some advice on how to become compliant as quickly and efficiently as possible.
Medical device manufacturers across Europe are staring into the eyes of an ominous deadline. The new EU Medical Device Regulations comes into effect on 26th May 2021, leaving some 27,000 manufacturers sweating on the compliance status of more than 1.5 million different types of medical devices. The time to act is now.
What are medical devices and what is EU MDR?
A medical device can be anything from a scalpel to an artificial shoulder socket; a pacemaker to a prosthetic limb. In order to improve the safety and traceability of medical devices, the EU has brought in new regulations (EU MDR) stating that medical devices sold in EU member states will need to be registered in EUDAMED with unique device identification codes from 26th May 2021 onwards. All codes - and therefore medical devices - will be indexed and registered on a central EU database called Eudamed - the European Databank for Medical Devices.
What does EU MDR mean for manufacturers?
“From the point of manufacture all the way through to end-of-lifetime, that whole cradle to grave process, for packaging now comes under the broader scope of EU FMD legislation.”
- Craig Stobie, Director of Global Sector Management, Domino Printing Sciences
The implementation of EU MDR obligates medical device manufacturers to invest in technology that facilitates the fast and accurate application of traceability coding to both product and packaging at the individual item level. It is also the manufacturer’s responsibility to make sure each product’s UDI code along with additional product-related information is registered in the Eudamed database - for every single item they produce. Failure to comply may mean manufacturers will no longer be able to supply their products to other EU member states.
How can manufacturers clear up any confusion surrounding the changes to regulations?
We need only look to the US for an illustration of the challenge’s companies face with coding and labelling. In the first quarter of 2018 the second most common type of device recall was due to mislabelling, which accounted for 73 of 343 recalls. Yet an early transition to the new regulations is crucial for manufacturers that want to gain a competitive advantage in the market. As we move towards the May 2021 deadline, healthcare facilities will increasingly prefer doing business with manufacturers who are already compliant - rather than those who are misusing the grandfathering clause. Compliance is also essential for any manufacturer wishing to bring new products to the market.
Adjusting to EU MDR will take time, effort and money. It’s far better to do that ahead of schedule, rather than holding off and panicking as delays become business critical.
“It’s key for manufacturers to engage with thought leaders and companies who already have a repository of knowledge on unique device identification - such as those who have already completed registration as well as notified bodies across Europe.”
- Volker Watzke, EU Medical Devices Sector Manager, Domino Printing Sciences
Domino has launched a podcast series designed to bring you the latest industry news and insights from the world of medical devices, international regulations and life sciences manufacturing. Our first episode discusses the impending challenges of EU MDR legislation and you can stream it for free right here for tips on becoming compliant as quickly and efficiently as possible.