Opinion: Is The EU Recreating A Different Monster Of A Regulatory Labyrinth?

This month, September 2024, marks four decades in my role monitoring EU regulations with Medtech Insight, and the legacy publication, Clinica – World Medical Device & Diagnostic News.

The pace of change in medical device technology, and in regulatory and political approaches, has been fascinating and at times staggering. And this momentum does not stop.

But while I have experienced three decades of what felt like constant progress, my reporting over the last decade has highlighted how the EU medtech environment is failing to deliver its objectives.

As all in the EU medtech industry know, we are on the cusp of regulatory change again in recognition of the regulatory setbacks that the EU has experienced and as AI especially, as well as many other forms of innovation, transform what technology can deliver to patients.

Challenging Questions

What is your opinion on how the regulations have changed over this period, one colleague asked me recently? And what do you think will happen next?

Tough questions. But let me answer by giving a bit of history first.

Exactly 40 years ago, when I started at the medtech desk of PJB Publication’s Clinica – the weekly hardcopy newsletter predating Citeline’s Medtech Insight, my articles were written longhand, then typed up by a typesetter!

There were no Europe-wide medtech rules and no internet to access information about the fragmented regulatory picture around Europe either. People relied on written material and that could be slow to come by. 

At that time, in 1984, the EU, known as the European Economic Community, was much smaller – with just 10 member states.

I first heard of efforts at medtech regulatory harmonization around 1987, when I attended my first conference in mainland Europe.

These were sectoral discussions that were taking place in the context of preparations for the launch of the EU’s single market in 1993.

There, the Germans and French insisted on speaking their native languages due to concerns about national identity loss with English becoming ubiquitously spoken in Europe.

The aim was harmonization of rules around Europe to avoid duplication of efforts and enable medical technology innovation to reach more patients more quickly and at less cost. The excitement in the sector was tangible.

These efforts resulted in firstly the Active Implantable Medical Devices Directive (1990), then the Medical Devices Directive (1993) and finally the IVD Directive (1998), the predecessors of the current Medical Device and IVD Regulations.

Of course, the EEC, renamed the European Union following the signing of the Treaty of Maastricht in 1992, has since grown significantly, reaching a total of 28 countries, until the UK left in early 2020 leaving a trail of ill-feeling.

The Challenges And Setbacks

EU regulatory harmonization at that time was not all plain sailing. Different countries were able to introduce some of their own rules as the directives were” transposed” into national law, rather than directly applicable as with the current medtech regulations.

Notified bodies were given what was later seen as too much freedom and there was insufficient oversight by regulatory authorities. This resulted in different standards among them and some substandard practices.  (Also see "EU notified bodies group acts in wake of spoof device report" - Medtech Insight, 27 Jan, 2015.) and  (Also see "The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While 'Wrath'-Behrendt Fumes" - Medtech Insight, 26 Nov, 2018.)

The PIP breast implant and the metal-on-metal hip implant scandals further undermined the directives’ reputation, as did the statement, in February 2011, by the then head of the US FDA’s Center for Devices and Radiological Health (CDRH), Jeff Shuren, that the EU was treating its patients as “guinea pigs.”  (Also see "EU Medtech Regulatory Overhaul Calls For Major Business Strategy Rethink" - In Vivo, 23 Sep, 2014.)

All the while new technology was emerging that would have been considered science fiction when I first started - 3D printing, exoskeletons, remotely guided surgery, to name but a few.

Questions about how appropriate the regulations continued to be as technology was becoming ever more complex coincided with an overdue regulatory revision.

The new Medical Device and IVD Regulations were adopted in 2017. In theory, they entered in full force in 2021 and 2022 respectively. In practice, this has not been the case as they have been beset by problems.

Fast-forward to now, and do we find ourselves in a better position in the EU? Have patients benefited and how is industry faring?

Cracks In The System

Of course, we would all expect some upheaval from the introduction of any new regulations and the Covid pandemic threw all actors off course for a time, but the reality is that the complexity of the new regulations, coupled with delays in implementing many key aspects of them have created an unwieldy environment and uncertainty in the EU that has been damaging for patients and for industry.

Many companies have turned away from Europe to launch new products in other markets, and many historic products have been removed from the market – not due to known safety issues – but due to challenges in compliance, not least given scarcity of resources, including at notified body level.

While, at the same time, the tables have turned with the US FDA having rationalized its regulations and having become a much better communicator with industry in a bid to foster innovation.

The result is that the EU has lost a lot of products and companies. And this downward spiral is continuing all the while that efforts are being made to stem the damage.

With political upheaval too, the threat of the far right and further damage to the EU after the UK and Switzerland have voted with their feet and are working hard on trade agreements with more far-flung countries, such as the US, it is hard to predict where this will lead.

The concern to me is a re-creation of the monster of a regulatory labyrinth that existed before the medical device directives unified rules EU-wide.

EU Medtech Struggling To Make Headway

I note that celebrating 40 years in my role has coincided with the publication of the Draghi report on the future of European competitiveness, which is highly critical of the damage that overregulation is doing to the EU industry in general.

Indeed, throughout my career, the EU medtech landscape has been characterized by optimism and progress. However, in recent years, this sentiment has been increasingly overshadowed by uncertainty and frustration. It feels like EU medtech is struggling to make headway, hampered by regulatory complexities.

The EU’s excessive bureaucracy while well-intentioned, may now be counterproductive. It is increasing costs and hindering patient access to the very treatments they were meant to protect.

I agree with the voices in the sector calling for a period of regulatory adjustment to ensure that patients across Europe continue to benefit from the best possible technology at affordable prices and in an equitable way.

To do this, the EU must strive for regulatory rationalization through more centralized controls and oversight and keep focused on the goal of true harmonization in an environment that fosters safe innovative products equally accessible to all patients.