EU Medical Device Regulation Postponed Due to Covid-19

The new Medical Devices Regulation (MDR) was set to be implemented from May 2020. But the new coronavirus pandemic has changed everyone’s plans – including those of the medical devices industry.

The European Commission (EC) decided to postpone the implementation of the Medical Devices Regulation so as to help Member States, their healthcare institutions, and economic operators focus on fighting the disease first. The MDR is now set to be implemented next year, in May 2021.

Adding to the news of the postponement, the EC’s proposal also tries to address any shortages of medical devices crucial to fight against the pandemic in the EU by introducing a new procedure. The EC will allow some medical devices to be placed on national markets and sometimes across the entire Union without a conformity assessment. In order for this to happen, national authorities need to justify the request, proving why it’s in the interest of public health or patient safety and inform the Commission and the other Member States.

The postponement is the chance for medical device professionals and businesses to analyse and study the new MDR in more depth until implementation arrives. We put together a white paper explaining everything you need to know about the MDR. From the main changes introduced by the regulation and the impact it will have on stakeholders, to the best practices your business should follow in order to comply to these changes, our white paper covers it all.

We should keep in mind that despite the MDR’s postponement, it’s still extremely important to keep investing in the safety and security of your medical devices, especially in these challenging times when medical devices will be relied upon by so many. Did you know that recalls are one of the main problems in the industry and that software faults are one of the top causes for these recalls? Knowing how software can cause these issues is one step to finding a solution to avoiding them. But it’s not just about recalls – cybersecurity in medical devices is also facing an array of threats. We created a short roadmap covering everything about building cybersecurity, from manufacturing to end users, which will help you identify issues and work out how to tackle them.

You can also check out our medical devices page for more information on industry challenges and tips on how to boost and strengthen your devices, be it their cybersecurity or their certification.