Less is more! Simplifying medical device regulations benefits us all

Can you provide some background? 

Sure. Today there are over 500,000 kinds of medical devices and in vitro diagnostics, including not only MRI or CT scan machines, pacemakers and hip replacements, but also more ‘everyday’ items like sticking plasters, contact lenses, digital health apps and pregnancy tests. And all of these products fall under the EU medical device regulations. 

It’s understandably a complex area to regulate, especially when we also want to encourage competitiveness and innovation.  

EU work in this area dates back to three Directives adopted in the 1990s - the Active Implantable Medical Devices Directive of 1990, the Medical Devices Directive of 1993, and the In Vitro Diagnostic Medical Devices Directive of 1998. Subsequent legal acts amended these directives, and they were heavily revised in 2017. 

This provided us with a comprehensive and ambitious regulatory framework, but the practical implementation of some of the revised rules revealed an overly restrictive and burdensome approach, which made compliance difficult, especially for micro, small and medium-sized manufacturers. This led to some devices becoming unavailable, among other issues.  

Our proposal simplifies things for manufacturers and regulators, helping to speed up the delivery of new and innovative devices while maintaining high levels of patient safety. 

Although our emphasis is on public health, the health of the EU economy is important too. The EU is second in the world for medical devices, and our market has been growing by 5.4% per year over the past ten years. In 2024, the European medical technology market was valued at roughly €170 billion, and it employs almost 1 million people, mainly in highly innovative small- and medium-size companies.  

What things are being simplified?  

I could provide a long list, but I will try to keep this simple too! One thing we are doing is reclassifying devices in a way that saves time and effort and is more proportionate to their inherent risk. For example, accessories for active implantable devices, like a simple screwdriver for a pacemaker, are currently in the same highest risk class as the implant. In the future, those accessories will be classified based on their own risk profile.  

Reusable surgical instruments have up until now been classified according to their area of use. Scalpels used for heart and brain surgery, for example, were classified as high risk, while scalpels used for knee surgery were lower risk. What really matters though, is not where they are used, but that they are cleaned and sterilised before re-use, and that this is verified by an independent third party. So this too, will change.   

We’re also going to drop the requirement to conduct clinical investigations on well-established technologies with a proven track record. Some, like dental braces and tooth crowns, were already exempted, but additional tried-and-true devices like catheters, needles and feeding tubes will now also be exempt.   

We are also modifying the obligation to re-certify devices every five years: they will be certified for their entire life cycle, although periodic reviews will remain. 

It will also be easier and quicker for a manufacturer to modify devices. Currently, if a manufacturer wants to make any modification, they must first ask a notified body and wait for clearance. The introduction of ‘predetermined change control plans’ will allow manufacturers and notified bodies to agree in advance on foreseeable changes, such as routine changes for software updates or manufacturing processes, enabling manufacturers to implement them faster without needing prior approval each time. 

Manufacturers will also no longer have to file periodic safety update reports at fixed intervals either. They will have to update them as necessary, when and if the benefit-risk ratio is called into question by real world experience. That said, manufacturers of high-risk devices, like implants, must continue to provide an update every two years. 

Similarly, we are reducing the frequency of the mandatory surveillance audits carried out by notified bodies, from annually to every two years if no safety concerns have been identified.  

Manufacturers of IVDs will now have access to expert panels, which they didn’t before, and these panels will include regulatory and technical experts as well as clinical experts. The European Medicines Agency, which already provides the secretariat for the expert panels, will also provide technical and administrative support to national authorities and coordinate their activities. 

Manufacturers will also have the right to correspond with notified bodies before and during the submission process. Some notified bodies, to remain unbiased, refused to talk to manufacturers until they had received the applicant’s full technical files for assessment. But that often led to incomplete files, delays and higher costs. We make it clear that pre-submission dialogues are acceptable, subject to clear rules and transparency.             

Is digitalisation addressed? 

Yes, in various ways, because digitalisation is the way forward, and the revised regulation should be future-proof.

Some of the proposed changes do away with the requirement for printed documents, instructions for use and handwritten signatures. Digital labels will be introduced, the electronic submission of documents will become the default option, and manufacturers and notified bodies will be permitted to fully digitalise the certification process, also leveraging the EUDAMED database. 

The proposal also validates innovative methods of collecting data, such as computer modelling and the use of digital twins. 

It’s a clear win for manufacturers and regulators, but what about for patients?  

Imagine having an unmet medical need, and knowing a solution is in the pipeline but isn’t available due to administrative delays. In the future, if an expert panel deems a new product to be a ‘breakthrough device’, the pathway to making the product available to patients will be expedited, provided the product meets all safety criteria.     

The proposal also helps reduce obstacles for developers of so-called ‘orphan devices’, which are used for fewer than 12,000 patients per year in the EU.  The notified body fees for these products will be reduced by 50%, which is only fair, given that the market is very small, but the development costs are high.  

A more predictable, streamlined and proportionate framework will ensure devices are available to EU patients when they are needed.  

What’s next?  

Citizens and stakeholders have the opportunity to provide feedback on the proposal until at least mid-March. The feedback will be summarised by the European Commission and presented to the European Parliament and Council, who need to adopt the text by ordinary legislative procedure for it to become Union Law. Follow the process  on the European Parliament website, and on the "Legislative Observatory" of the European Parliament. 

Link to follow article:
Factsheet - Better rules for medical devices, better outcomes for EU patients   

To provide feedback on Proposal:
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en