The European Commission’s three-month public consultation on EU medical device regulations (MDR and IVDR) has already revealed widespread frustration and anger among stakeholders across the sector.
Over one hundred responses submitted within this first month from the EU and beyond paint a picture of a system plagued by complexity and excessive costs, and one that is having negative impacts on innovation and patient access.
None of this will be a surprise to the commission during its search for ways to improve the regulation of devices in the EU. It has heard it all before. And although it has not yet addressed the system’s basic failings, the point of the current exercise is to gather feedback on the effectiveness, efficiency, relevance, coherence and EU added value of the Regulations on medical devices from 2017 to 2024 and use this information to find workable solutions.
The consultation ran from 12 December 2024 and finishes on 21 March 2025.
Constructive Proposals
While many responses appear more focused on criticism, some clearly offer constructive suggestions.
Among the recurring themes for constructive proposals are the following:
- Streamlining and simplify the process for low-risk products, and devices with established clinical backgrounds.
- Establishing common notified bodies fees based on manufacturer size and clear and transparent timelines.
- Accepting existing technical files subject to surveillance audits for all but legacy implants and class III devices or differentiating requirements between older and newer legacy devices.
Key Criticisms
Respondents repeatedly cited the excessive complexity of the regulations and the associated costs, particularly for small manufacturers dealing with legacy devices.
The complexity of horizontal regulations impacting medical devices, in addition to the existing challenges in implementing and meeting the demands of the Medical Device and IVD Regulations, is adding to the industry’s challenges.
Indeed, one contributor lamented that the EU regulations are too complex to be implemented without the help of “very expensive and hard to get consultants.”
Opacity surrounding notified body costs and timelines was also criticized, with some having comes across inflated prices and “fast-track” options at exorbitant rates.
Many, of course, feel the burden is unsustainable and are deciding to cease manufacturing products or exit the EU altogether. Unsurprisingly, there are also comments on how the regulations are stifling European innovation, and driving businesses to regions with more industry friendly markets, such as the US.
Concerns about product shortages and the withdrawal of EU-manufactured products are common observations among responses. “This forces reliance on non-EU sources and potentially compromises patient care,” one submission suggests.
Others called for more clarity. One contributor representing public hospitals in France said that hospital engineers do not know which laws, regulations or directives to refer to when seeking new medical equipment “because most companies do not comply with the MDR. And when they do, they inflate prices by two or three times.”
Harsh Comments
Particularly direct and harsh criticism came from many diverse sources. Among them are the following:
- A Dutch orthopedic clinic described the rules as “over the top,” citing product shortages and rising costs.
- A Belgian company termed the situation “a mess.”
- A US company labeled the MDR as “terrible for EU patients and doctors. The egregiously high burden of complexity, regulation and cost especially for small manufacturers with simple legacy devices is unsustainable,” it said.
- A UK company described the last two years as “spectacularly difficult.”
- A French sports clinic stated the regulations are “killing European innovation.”
- One US contributor called the regulations a “costly mistake,” citing wasteful processes and no tangible benefits, while another called it “at best, a disaster.”
What The Commission Needs
The commission will need to carefully consider the proposed solutions to effectively address the widespread concerns but wading through the comments, which could easily reach 300-400 by the end of the consultation period, will be a tall order.
It is likely to skim-read the criticisms, which are already familiar. What it will be looking for is new suggestions to help improve the regulations.
What could arguably benefit it most is suggestions in the form of a punchy submission made, for example, by an Italian medical devices company: “Simplify the process for low class products, software without risk to the patient or any medical device with a real clinical background, regulate the daily fees of notified bodies (hello “fast track” at 10k/day) by creating common assessment costs for all notified bodies based on the size of the manufacturer requesting it, introduce a maximum notion of deadlines for registrations as proposed by the FDA for both new dossiers and substantial design changes …”.
Context And Next Steps
In view of the significant challenges encountered in transitioning to the new rules, while Articles 121 MDR and 111 IVDR require the commission to conduct an evaluation by May 2027, the commission decided to launch a targeted evaluation of the Regulations in 2024.
A factual summary report on the replies to the public consultation will be published on the commission’s consultation page once the public consultation has been closed.
