Implementing the Medical Device Regulation (MDR) has kept the medtech sector extremely busy over the last couple of years. The MDR entails wide-ranging changes and has led to considerable uncertainty. So it’s likely to come as some relief that, faced with the COVID-19 crisis, the EU has chosen to postpone application of the new regulations for a year. A cause for celebration? Maybe, but companies should rather be too busy taking advantage of all the exciting opportunities the postponement creates to celebrate. And not just medtech companies – the postponement also affects the pharmaceutical sector.
May 26 was to have been a big day for the medtech sector. So tantalisingly close, this was the much discussed, eagerly anticipated, but also dreaded and much criticised date on which the Medical Device Directive (MDD) was to be finally replaced by the MDR. On April 17, 2020, however, little more than a month before impact, the approaching iceberg suddenly found itself edging back towards the horizon, taking with it a vast pool of uncertainty and urgent problems – for another year at least.
From publication of the “Proposal for amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions” on April 3 to adoption of the amendment on April 17, it took just two weeks. In terms of European Parliament and Council decision making, the speed with which the amendment was passed is quite remarkable and simply wouldn’t have been possible without the coronavirus crisis. The impact of the postponement should not be underestimated.
The new date is important not just for the medical technology sector, but also for the pharmaceutical sector because the more specialised a pharmaceutical company’s business model, the greater the likelihood that MDR will involve significant changes for them as well.
The iceberg is gone – long live the iceberg
Some in the medical technology sector were calling for a postponement of the MDR even before April 3. The problems caused by a dearth of notified bodies (just 13 on April 27, 2020, compared to more than 50 under the MDD regime), the failure to constitute expert panels, the paucity of guidelines and detailed documentation, and delays to the EUDAMED database (the introduction of which was, in late October 2019, pushed back to May 2022) appeared insurmountable. In the end, however, it was the exceptional circumstances surrounding the COVID-19 pandemic that led to the original implementation date being abandoned. The postponement should ensure that manufacturers and notified bodies have the capacity to rapidly develop and approve life-saving equipment for treating those afflicted by the disease. The delay in MDR implementation also means that the transitional provisions will be extended by a year:
- Products can still be approved under the old MDD regime until May 26, 2021, after which they will continue to benefit from the 4-year transitional period.
- Products with MDD certification will not have to implement the more stringent market surveillance mechanisms (PMS. PMCF, PSUR) until May 2021.
- The situation in Switzerland is slightly different – the mutual recognition agreement between the EU and Switzerland remains valid for a further year, and Swiss manufacturers can continue to market their products in the EU during this period.
For the time being, therefore, and until May 26, 2021 everything stays just the same. Time to sit back and relax? Not a bit of it – but it is time to take advantage of some unexpected opportunities.
The MDR is postponed – so what now?
Though manufacturers were made aware of the date on which the MDD would be repealed by the MDR well in advance, a lack of clarity in certain areas and other uncertainties meant that many had put off implementation to the point where they eventually found themselves under severe pressure to get it done on time. As a result, many businesses have ended up having to adopt solutions that are far from satisfactory.
- Many companies have chosen to rely on the transitional period for certification under the MDD. Because notified bodies more or less stopped accepting applications for certification under the MDD regime after autumn 2019, this has had the disadvantage of leaving them unable to undertake planned or essential revisions, as any changes would have forced them to apply for approval under the new MDR regime.
- Products which were assessed as not being worth the effort of being put through the new approval process or for which approval under the MDR was not considered feasible within the time available have been abandoned and were set to be withdrawn from the market.
- To enable them to be sold where possible during the entirety of the transition period, large quantities of MDD-certified products were produced in advance.
- In the absence of the ability to extend MDD certification, companies have put off launching and developing new products.
The 12-month delay to the implementation date opens up new opportunities for established manufacturers, new market entrants and start-ups alike. We have been talking to lots of medtech companies over the past few months, and have identified the following opportunities in particular:
- The delay means it is now possible to make “significant changes” to products (changes that alter the intended use, design or performance of the product or involve changes to software or materials) and still have them approved under the MDD regime. This means that improved products and new developments can now make use of the 4-year transitional period starting in 2021.
- New products can still be approved under the MDD and take advantage of the transitional provisions post 2021. This is, however, conditional on notified bodies accredited under the MDR being willing to continue to process MDD approvals or notified bodies accredited under the MDD extending or resuming their activities. Though little has been said publicly, some bodies have signalled that they might be willing to undertake such projects.
- The delay also offers an opportunity for products abandoned due to time constraints to be advanced to the point where they are in a position to extend their certification under the MDD, are eligible for certification under the MDR, or at the very least can continue to be marketed through to May 2021.
It’s important to note that the above list focuses on technical factors and does not consider other issues. Non-technical issues are also worth a closer look, but are outside the scope of this article.
Don’t have the resources to take advantage of this opportunity?
Since the delay to MDR implementation was simply not in the offing when annual budgets were decided and because R&D departments will have scheduled other work, it’s likely that many companies don’t currently have the resources either to undertake development of new or existing products, or to reactivate products, test systems or platforms. This problem can, however, be circumvented by using external contractors able to meet this short-term need by executing projects either autonomously or in conjunction with inhouse R&D departments.
As well as taking advantage of the opportunity to revisit existing products, medtech companies should also give some thought to whether they can use the extra year to make their products fitter for the future. We see a number of trends in the medical technology sector which are definitely worthy of further scrutiny.
- Connected devices: Bringing existing devices online gives manufacturers direct access to patients and doctors. Connected devices can be modified to collect and process product data, which can be used to automate or improve the efficiency of some market surveillance tasks. In the long term, they can also deliver new revenue streams.
- Big data: Data is the currency of the future. From usage statistics to personalised treatments, being fit for the future means collecting, processing and securely storing structured data and having the right infrastructure for doing so.
- Mobile apps and customer experience: The COVID-19 crisis has cruelly demonstrated that it’s no longer safe to assume that we will always have access to medical equipment at medical centres and hospitals. Help is at hand, however, in the form of home medical devices and devices operated using mobile apps with simple interfaces.
- Digitalised processes: Right now is a good time to set about tackling the long overdue task of digitalising internal processes and documentation. The right tools and paperless processes will save lots of money going forward and create a strong foundation for a more flexible, pandemic-resistant setup.
What about pharmaceutical companies?
Although the MDR only covers medical devices, and not drugs, etc., the delay in MDR implementation also has potential implications for the pharmaceutical sector. Article 117 of the MDR, for example, requires applications for approval of integrated combination products to demonstrate that the medical device parts meet any applicable general safety and performance requirements set out in the MDR. Class Is, Im, Ir, IIa, IIb and III integrated medical device parts additionally require the submission of a notified body opinion.
This additional requirement has, understandably, led to much uncertainty in the pharmaceutical sector, where GxP guidelines are the gold standard and medical device regulations much less familiar. Here again the extra time represents an opportunity to ensure readiness to meet the requirements set out in Article 117.
MDR postponement has been an unexpected gift, so it’s all the more important to ensure that this gift and the extra time it provides are not wasted.
Interested? We would be very happy to discuss the opportunities and available options with you.