The Industry View of EU MDR Implementation and Delay

Over the course of 2020, we have conducted numerous studies of the industry. Here we look at how the survey respondents view the EU MDR implementation and subsequent delay.

The Industry View of EU MDR Implementation and Delay

Over the course of 2020, MedTech Summit and Informa Connect Life Sciences have conducted numerous studies of the industry, surveying medical device professionals from across Europe and beyond. Here we look at how the respondents view the EU MDR implementation and subsequent delay.

In February 2020, before the true scale of COVID-19 was apparent and before the extension to the EU MDR deadline, 265 medical device professionals responded to our survey around EU MDR compliance, implementation and preparedness.What was clear was that many felt their company was not prepared for implementation, and many were extending their certificates under the existing Medical Device Directive (MDD), potentially up until May 2024.

How prepared do you think your company
is for EU MDR implementation? (Feb 2020)

Just 17% of medical device professionals thought that their company was 'fully prepared' for EU MDR implementation before the delay.

Of those not fully prepared for implementation, a lack of guidance dominated the reasons why (selected responses):

"A lot of procedures still need to be updated and some require guidance docs that are not yet available."
"There is a sense of confusion, compounded by Brexit."
"The lack of guidance and Notified Body experience."
"My company initially underestimated the effort to become MDR compliant AND there is a clear lack of guidance from the Competent Authorities."
"Discussions about some interpretations, guidances which are not written or published, timelines which are not realistic anymore."
"Incomplete standards."
"Insufficient time to prepare due to Notified Body withdrawal causing other more immediate issues."
"Lacking people, IT resources and legal consultation."
"There are many unknowns; we have actions in place and believe we have covered off the elements required, but with interpretation issues in the mix, who knows?!"
"Still finalising some aspects of PMCF and technical file templates."
"Notified Body uncertainty and hence ability to plan."
"Our Notified Body is not yet designated to the EU MDR."
"UK govt (MHRA) guidance delayed. Lots of minor issues, but in house manufacture a key one."

"Companies feeling the pressure to be EU MDR-compliant wanted more guidance from the European Commission than they were getting, as well as more time and resources, including capacity at Notified Bodies. Around a third of respondents wanted to see more Notified Bodies in place, reflecting the fact that the number of Notified Bodies designated to work under the EU MDR was far below what industry had expected.

Specific comments from respondents also highlighted concerns about the Notified Bodies’ frequent struggles to find enough resources to certify all companies. They feared that Notified Bodies are unprepared, with an insufficient number of auditors and a lack of understanding about how long it will take to gain CE marking under the EU MDR."

- Philip Greenfield, Editor-In-Chief, Medtech Insight

Which of the following do you need more of to be fully prepared for EU MDR implementation?

"While a vast majority of companies felt they were prepared for the new regulatory environment to some degree, three quarters were extending their certificates under the existing Medical Device Directive (MDD), potentially up until May 2024, and most were planning to use the entire MDD certificate time to get MDR-ready." - Philip Greenfield, Editor-In-Chief, Medtech Insight

What proportion of your products have you
extended your MDD certificate for?

*Excluding 'Not Applicable' (63)

67% of respondents are planning on using their
entire MDD certificate time to get EU MDR ready

*Excluding 'Not Applicable' (70)

In April 2020, following the global outbreak of COVID-19, we conducted a second study around the response of the medical device industry to the crisis and the impacts that delaying the EU MDR Date of Application (DoA) would have.

Many of the 178 medical device professionals that responded saw the delay of the EU MDR as a positive move, offering manufacturers and Notified Bodies more time to prepare for the change, or else believed that in the long term, the delay will have minimal impact. question.

Reaction to the EU MDR delay post-COVID-19

What do you think the long term impact will be from delaying the EU MDR by a year in light of COVID-19? (Selected Responses)

"A few more manufacturers may be ready to go if they get an additional year to prepare.""Allows more Notified Bodies to be approved for MDR designation. Allows companies to be more prepared.""Both industry and the regulators will have more time to to put plans in place for compliance.""No major impact. It was already very difficult to meet the timeline for Notified Bodies, authorities and companies. I think this delay will only bring a more realistic timeline.""Hopefully all companies can focus on getting their MDR documentation and registrations ready. And hopefully we can have all the necessary NBs certified in time for the new MDR DoA.""It will allow more companies to comply in time as there are delays and change in processes in the industry at the moment. It will likely have a positive impact on industry that has invested already in meeting compliance but is facing delays and unlikely to cause any long-term negative impact on the regulatory compliance.""Minimal - most manufacturers on the MDR pathway need to forge ahead as if no change. Manufacturers that are still in the implementation stage will get some relief. Manufacturers utilizing MDD certificates until May 2024 will continue as planned. Biggest relief will be for NB and CA to be better prepared by May 26, 2021.""The Notified Bodies will have more capacity for COVID-19 related devices / tasks. With regard to quality requirements, I think there will be no long term negative impact as MDR will be coming anyway.""None. Companies which are not prepared by now will not be prepared in one year. Neither the quantity of Notified Bodies nor the quantity of qualified employees of the Notified Bodies will increase rapidly as everybody is focusing on COVID-19.""Since the preparation for MDR was a difficult and costly process for many manufacturers, the delay may be financially advantageous for some manufacturers and help them to survive difficult times.""It might decrease the pressure on companies directly dedicated to the investigation of COVID-19, and will allow them to dedicate their efforts to this real problem across the world. Highly safe medical devices have been developed till now with the current legislative framework.""Lets get the right products made correctly and appropriately with CE and reg approval asap, not cut corners. Work on making the process easier and smoother, not removing reg approval completely.""MDR aims to ensure the manufacture of safe and effective devices and motivates for innovation. There is a risk that this group of manufacturers, who are not capable or not willing to meet these requirements, have now enough time to prevent the success of the MDR.""More devices and hopefully more Notified Bodies.""This may not be long enough and will need to be reviewed again.""Very little if the companies impacted by the EU MDR have been working since 2017 (like they should have been) to become compliant. For those companies that haven't been working towards compliance, it gains them a year to hustle and get compliant products.""The impact of COVID-19 is probably much bigger than the MDR delay. This delay was needed anyway, so now the process can run smoother."

Does delaying the EU MDR DoA solve the issue of needing more respiratory devices/tests to hit the market or raise new challenges?

Respondents were conflicted when asked about the effectiveness of delaying the EU MDR DoA in solving the issue of needing more respiratory devices and tests to hit the market in response to COVID-19. The majority said it would raise as many challenges as it would solve the issues.

Should regs be eased to allow for non-medical manufacturers to help with the shortage of PPE and respiratory devices?

And finally, away from the EU MDR, we also asked the industry for their opinion on whether regulations should be eased to allow for non-medical manufacturers to help with the shortage of PPE and respiratory devices. The response was a resounding yes, with 70% agreeing.