The European Medical Device Regulation (MDR) is a new set of regulations governing the production and distribution of medical devices in Europe, which were due to come into place on 26 May 2020. Designed as an update to the Medical Devices Directive (MDD) of 1993, MDR focuses less heavily on the pre-approval stage of medical device manufacturing and instead leans toward a more lifecycle-focused approach.
The implementation of the regulations has been delayed for a year to allow the European medtech industry to focus on the ongoing Covid-19 crisis.
The new MDR regulations are four times longer and contain five more annexes than the MDD, and will require most companies to update their clinical data, technical documentation and labelling. The regulations have broadened the definition of a medical device to include: active implantable medical devices (AIMDs) which were previously categorised separately; software as a medical device (SaMD); products for cleaning, disinfection or sterilisation of medical devices; and previously non-regulated non-medical or cosmetic devices like liposuction equipment or epilation lasers.
Many medical devices have also been reclassified as higher risk. This will have a significant impact on in vitro medical devices, which are now divided into four risk classes and will require notified body (NB) review about 90% of the time, compared to the current 10%.
NBs are organisations given authority by the EU to approve medical devices for CE marking and the MDR has a significant impact on them too. NBs are being required to re-apply for their designation with the EU, and will now be audited by their local Competent Authority, as well as that of another EU member state and representatives of the European Commission. They will be required to demonstrate an increased degree of technical expertise and improved quality management steps.
So, how are medtech companies responding to the regulatory delay? Verdict Medical Devices spoke to three different organisations in the sector to see how the situation is impacting them.
We’ve heard from:
- i-SEP scientific regulatory affairs & quality director Patricia Forest-Villegas
- Speciality Fibres and Materials (SFM) managing director Amanda Ling
- S3 Connected Health president Jim O’Donoghue
What will be the upsides/downsides of the new MDR for your business?
Patricia Forest-Villegas: The Covid-19 crisis had an impact on the company’s schedule, implying a delay in our clinical study and therefore in the submission of the technical dossier now scheduled for 2021. In the event that the MDR was not postponed, we could have benefited from a first review experience of NB according to the MDR. That being said, our NB already works according to the MDR and advises all its customers to continue their compliance with the MDR so the consequences are a priori minor.
A potential risk is also that the planned bottleneck of the NB at the time of the MDR application initially planned for May 2020 will be postponed to May 2021, which could have an impact on the timescales for review by the NB of our technical dossier. We are working closely with our NB to establish a schedule even if it’s a lot ahead.
Amanda Ling: SFM manufactures alginate and modified cellulose dressings with or without anti-bacterial actives for the advanced wound care industry. The EU MDR represents a real opportunity to add value into our supply chain. However, there are also some challenges which we have had to prepare for, well ahead of the original intended deadline.
I guess the silver lining for a business like ours is that we have an experienced regulatory team, and we are able to credibly navigate the new MDR, and also offer support for our customers and partners. It also means that certain medical device providers who perhaps had less stringent processes will struggle to introduce their products in the EU, and support their customers with MDR requirements, thereby making experienced and mature companies a more credible and attractive partner going forward.
Jim O’Donoghue: Both medical device vendors and NBs were already struggling to ready themselves for the new regulation, even without the impact of Covid-19. There were 50% more certificates issued in 2019 compared with the year before as vendors rushed to certify before the deadline, while approved NBs numbered only 13 as of April this year.
The benefit of the delay is that it removes a significant bottleneck; providing time for both device vendors and NBs to ready themselves for more stringent regulations. It also gives vendors more time to add connectivity to their devices – something that will prove particularly useful given increased clinical evaluation and monitoring requirements under MDR – and ensure that all data is handled as scrupulously as possible. The downside – though perhaps minor – is that those who have been readying themselves for a long time for MDR certification will now have to revisit those plans.
How has the delay impacted your business?
AL: The delay will provide us with additional time to pilot what we have implemented in readiness for MDR. In addition, we recently identified an opportunity to add one of our products into our current CE Mark, and this is certainly simplified by the transition being delayed until next year. I guess the main impact for us has been the extra headspace, which was welcomed, for the business to focus on measures across our business against the Covid-19 pandemic. It certainly has allowed us to focus on business continuity and plan for the rest of 2020 and 2021.
JO: As a result of the development, we’re revisiting the planning process with clients to meet the new timings. That extra year-long window to get Class I devices on the market will be very much welcomed, especially as we all continue to deal with the impact of the pandemic. We’ve seen first-hand how recent events have forced big, tier-1 medtech companies to change their priorities and put the brakes on existing non-essential programs in order to deal with the Covid-19 pandemic.
We ourselves welcomed the receptiveness of regulatory authorities to act quickly in the current situation. Our clinical support tool, ACORRD – designed specifically for the pandemic to help clinicians triage, monitor and treat Covid-19 patients – received the necessary certification under MDD in two months, a narrow window that would be even more stringent under MDR.
What do you make of the delay overall – is it a crucial step to allow businesses to prioritise their Covid-19 responses or is the EU shirking its responsibility to modernise legislation for the medtech industry?
PF-V: This postponement was without doubt necessary both for the companies and for the European Commission. It is obvious that a huge number of companies were already late in achieving compliance with the MDR and that the Covid-19 crisis did not help anything. On the other hand, it also seems that this postponement is beneficial for the Commission to finalise their compliance and to establish all the guidance allowing the full implementation of the MDR.
Finally, it’s obvious to say that the NBs have already started largely to align their requirements with those of the MDR even though the MDD is still in application. This therefore just increases the transition time to a more efficient regulation, but it would be illusory for a company to turn a blind eye to MDR and continue according to the MDD despite the postponement.
AL: The delay of EU MDR by one year was absolutely critical for the medtech industry to focus on its Covid-19 response. It would have been foolish not to delay! It will take months to get back to pre-Covid-19 levels and so the focus had to be on business safety and continuity. I know a few peers in the industry will welcome the additional breathing space, and no matter which way we look at this, the EU MDR is a paradigm shift. It is an extra year to strategically prepare our businesses.
JO: The delay was very much a crucial step. The industry and its regulatory authorities simply weren’t ready for MDR, even without the Covid-19 pandemic, and, once the pandemic arrived, a likely delay became absolutely essential.