This is no time to further unsettle EU medtech legislation

Posted on 28.08.2023

Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation.

As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we have all worked through our share of challenges.

Our industry has worked hard to implement major new legislation while coping with other pressures. The Medical Devices Regulation (MDR) entered into full legal application in May, and we continue to work tirelessly to prepare for the application deadline of the In Vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022.

Those of us who lived through the drafting and redrafting of those heavyweight legal texts can attest to the complexity of the process.

The regulations will support a level playing field amongst approval bodies and the scope has been tightened up and includes more product groups. There will also be more oversight from authorities, and transparency on products will increase significantly.

All of that will hopefully significantly strengthen the trust in the CE marking system, medical technologies and the new legislative framework alike.

Nevertheless, there are already signs that the increased complexity for getting to the market – including new post-market responsibilities – may be turning some off investing in innovation or launching new technologies on the European market.

Policymakers, industry and other stakeholders have made considerable efforts to ensure ex ante that the MDR and IVDR protect patients and promote access to innovative products and solutions. Medtech innovation, it should be said, is in the interest of patients and consumers. The philosophy embedded in the MDR and IVDR reflects this need.

Today, I must confess to a sense of unease when I hear talk of complicating matters further by revising the Product Liability Directive (PLD). The PLD aims to protect consumers from faulty products, giving them recourse when things go wrong, while at the same time ensuring operators’ competition. We have all benefited from these kinds of consumer protections.

The PLD dates back to 1985 and, not surprisingly, does not cover some of the digital tools on the market today. This does not yet justify a total re-opening of the Directive including questioning the fundamental principles that have been working very well for years as they allow for enforceable consumer protection whilst providing industry with a clear and predictable legal framework to operate and innovate within. This philosophy is well recognised and should not be jeopardised.

The Directive also leaves the courts with sufficient sovereignty to ensure consumers are afforded appropriate protection in the real world. For patients and industry alike, whether we are talking about traditional or connected/software medical devices, this balance which is the principle on which the directive was based, also delivered the innovative healthcare we all benefit from today.

In short, suggestions to rewrite the principles of the horizontal legislation and apply them to products and solutions which are already regulated with the most modern legislation, including strong consumer protection and liability provisions, would risk unpicking a carefully woven legal tapestry. It would create legal uncertainty due to overlap of provisions. We all know that this is a barrier to bringing needed innovation to patients and healthcare.

We are acutely aware that reopening such a complex and far-reaching file as the PLD and putting everything on the table would make it very difficult, if not impossible to square with other legislation, including the MDR, IVDR and GDPR – not to mention offending the EU Better Regulation principles.

European policymakers may have already moved beyond this option, but personally I believe that a more dynamic alternative would be to issue guidance on how to interpret the existing PLD framework for emerging technologies and trust national courts to apply it accordingly. This would allow us to keep the benefits of the existing PLD and also cope with the inherent uncertainties that come with advances in artificial intelligence, the unpredictable risks that could arise from cybercrime, and other issues that may emerge in the near future.

As we recharge our batteries ahead of a busy autumn, we must tread carefully to avoid undoing the work we have done in the past.