EU MDR: Learning as We Go

Regulatory NewsRegulatory NewsRAPSRAPS' Latest | 20 February 2020 |  By 

With full application of the EU Medical Device Regulation (EU MDR) just around the corner on 26 May 2020, it’s fair to say many device manufacturers and regulatory professionals are on edge. And although we are coming to the end of the three-year transition period, it’s sometimes seemed like we have been struggling to play catch up from very start of the process.
Some of that is in the nature and scale of EU MDR as compared to the Medical Device Directive that has been in place since the 1990s. EU MDR is much more comprehensive than the MDD. While the MDD was just a handful of pages, the new regulation is hundreds of pages. It is much more detailed and much more prescriptive.
Industry stakeholders, notified bodies and government authorities are feeling pressured to get everything fully correct straight out of the box. But we don’t have all the answers, and we aren’t likely to – at least not right away.
MDD Also was a Major Adjustment
I was working for a notified body in 1993 when the MDD came into force. It followed the Active Implantable Medical Device Directive and preceded the In Vitro Diagnostic Directive. I can tell you from personal experience that we didn’t have all the right answers on day one. We were all learning how to interpret the directives and how to apply them in practical terms to remain in or achieve full compliance. The necessary guidance was yet to come and there was a lot of ambiguity. We didn’t yet have experience or even fully established expectations.
Frankly, we got some things wrong in the beginning. Notified bodies were still learning their roles. What notified bodies and manufacturers were doing to comply in 1993 was different from what they were doing a decade later with the benefit of years of practical implementation.
Right now, on the eve of EU MDR, I think we are in a much stronger place than we were in the 1990s – today we have far more sophisticated resources and experts.
Before the MDD, manufacturers did not have to comply with a single, consistent regulatory approach for all of Europe. They had been conditioned to comply with different expectations for each country. With EU MDR, the requirements may change, but manufacturers today are used to having a single European approach.
Learning as We Go
While there are still many questions regarding EU MDR, it’s worth noting that guidance for the MDD took over 20 years to develop and put in place. It wasn’t all there at the outset. Now, as then, we must learn as we go.
Despite the pressure, neither manufacturers nor notified bodies nor Member States have all the answers. Everyone is reading the text, reading the requirements, interpreting them and trying to make sure they are doing enough to comply.
Figuring out how much is enough is one of the biggest challenges now. Many are concerned about updating clinical evaluation reports to comply with today’s expectations. But I would argue that if you were doing clinical evaluations correctly under MDD best practices, the gap between that and the EU MDR requirements may not be as great as you think. The largest compliance gap to fill will be for legacy products that were in compliance 10-15 years ago, but haven’t kept up with the state of the art.
Pragmatism and Patience
Some of the more pragmatic competent authorities realize that we are in transition to full compliance, and even those companies that are in good shape to be MDR compliant in May likely will have adjustments to make. We are going to have to calibrate as we go for the next few years.
We learned so much as a notified body under the MDD by seeing how manufacturers worked to comply. We anticipated what we thought was needed and what we thought manufacturers would do. Sometimes manufacturers had different, unexpected ways of addressing requirements. Sometimes we felt they might have had it wrong, but other times we learned there are different ways of doing something while still meeting the regulation’s intent.
I believe we are all on this journey together, and I don’t think it’s realistic to think everything is going to be perfect from the beginning. But we are building confidence, we are calibrating, and we are adjusting. And that will continue to play out for years beyond 26 May 2020.
Patient Health and Safety are top Priorities
Some have warned of the potential for device shortages. I think this is where competent authorities and Member States may have to have to tolerate some degree of noncompliance as long as it does not endanger patients. They will have to judge which noncompliance issues are safety risks and which are administrative or bureaucratic hurdles. Unsafe situations cannot be tolerated. But, for example, perhaps there will need to be some acceptance of a product that has been on the market for years with a good track record but still lacks fully updated documentation to be completely MDR compliant.
I imagine most manufacturers are still without MDR certificates. Many products that are already CE marked under the MDD have the possibility to stay on the market under a four-year grace period ending 26 May 2024. In December, the European Parliament’s Committee on the Environment, Public Health and Food Safety voted to adopt a corrigendum that provides the possibility for devices that are currently CE marked and are up-classified under MDR may also benefit under the four-year grace period before being fully MDR compliant.
A Chilling Effect on Europe’s Device Market?
The EU system has made Europe an attractive place to launch new medical devices, but many are wondering if MDR will change that. Some in industry think it will. Perhaps complying with FDA requirements will be viewed as more predictable, more straightforward and less onerous in many ways.
Notified body capacity is part of that, but it’s not only that. The requirements for clinical evidence and clinical data are significantly stepped up under EU MDR. Significantly more clinical data – specific to the actual product – is required, particularly for implantable or high-risk Class III products. So, manufacturers are going to have to do more clinical investigation for the products they launch. It might be more attractive to go with the predictable clearance times under FDA regulations.
The European system has been largely successful in getting safe and effective products to patients quite quickly. Under EU MDR, manufacturers may start to ask whether Europe is a market they want to go to first. It’s still a big, important market that can’t be ignored, but time will tell if more companies look to launch in the US before Europe, a reversal of the way it has been for some years.
If that happens, I think many will begin to ask if the pendulum has swung too far, and perhaps we will see some adjustments. Regardless, there are companies that are successfully meeting EU MDR requirements, and we all must learn from one another. Just as it was with MDD, it will be a long and evolving process to full compliance.

Correction/Clarification on 25 February 2020: The original article should have stated that most, not “quite a few,” manufacturers’ devices are without MDR certificates; that the grace period for full MDR compliance for MDD-compliant devices is four years; and that per the December 2019 corrigendum, the up-classified Class I devices that will need a notified body will also have a four-year grace period. Regulatory Focus regrets the errors.


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