On 26th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’. It further aims ’to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector’. ’Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other’, it states. I could not agree more with these phrases. There are two main objectives that are inextricably linked and need to be balanced: safety and innovation are mutually dependent.
Fortunately, there are thousands of innovative ideas designed to improve people’s lives. The European Patent Office (EPO)[1] data for 2020 shows that the medical technology sector made the highest numbers of applications – 14,295 to be precise – putting it ahead of digital communication, electrical machinery, energy, transport, pharmaceuticals, and others.
But the medtech industry is telling me a different story about the future!
Many innovation projects in times of implementation of the MDR are being abandoned while improvements to existing products are no longer being made. Where manufacturers are seeking regulatory approval of medtech innovations, geographies beyond Europe with faster and more predictable pathways (e.g., in the US and others) tend to be preferred, at least for now.
We are facing an imbalance between the above-mentioned goals of the MDR. More and more often I hear that products that are certified under the provisions of the old directives pose a safety risk to the patient. Personally, it feels like the wording ’patient safety’ is not only weighted as one of the most important goals of every medtech actor but is sometimes misused as a defence against considerations towards improving the functioning of the European internal market.
I feel that if the balance between safety and the functioning of the internal market keeps tipping, it will severely challenge Europe’s position as a location for the medtech industry. And even worse, it will have a severe impact on European healthcare and patients.
Businesses are already starting to turn their backs on Europe. Their first route to market is shifting to other markets where there is a growing realisation that market authorisations must become leaner. As a consequence, whole R&D departments are relocated to these countries. In the worst-case scenario, significantly fewer innovative products will reach European patients.
So, what are the roadblocks to innovation in Europe?
We know that there are thousands of good ideas. We know that failure is an important part of successful entrepreneurship. However, failure is becoming far too expensive in Europe, as approval costs under the MDR are estimated to be between two and four times higher than before.
And the negative outlook it is not only about cost. Innovation in general is not supported enough under the MDR. At least not as long as companies are forced to focus on recertification of their existing products simply to ensure their continued availability for the health care system. If a route to market is uncertain and overall costs remain non-transparent, Europe has a problem.
As European people, and as patients, we are entitled to be highly alarmed. While the US is streamlining the framework conditions for medtech innovation, Europe is saddling itself with complexity and uncertainty.
Europe has to realise that if we continue like this, there is a high risk that in the short term we will lose our place as a location for medical technology. And with that, highly innovative SMEs will suffer.
So, what do we need to do?
We need a stronger European industrial policy. We need inter-ministerial cooperation as well as integrated industrial, social and economic policies. We need more dialogue and greater attention to the concerns of all stakeholders. We need a much more pragmatic approach to the implementation of the MDR.
And we need closer collaboration between policymakers, authorities, industry and clinics to ensure that future medtech innovations continue to come from Europe. While the challenge is considerable, I believe we can find a way out – together.
