Written by the European Hearing Instrument Manufacturers Association (EHIMA) 

On 16 December 2025, the European Commission published its long-awaited proposal to revise the Medical Devices Regulation (MDR). EHIMA strongly supports this revision, which represents a necessary course correction of the EU’s medical device framework. At the same time, as the proposal moves forward, it will be crucial that its implementation avoids new layers of complexity, ensures alignment with AI and cybersecurity rules, and consistently applies a risk-based regulatory logic in practice.  

The proposal marks a major recalibration of the framework adopted in 2017. It offers the chance to fix various unintended consequences caused by the current MDR and bring about a nimbler, more pragmatic system that better supports technological innovation and access to advanced hearing care across Europe. The MDR has undoubtedly strengthened patient safety and market oversight across Europe. At the same time, its implementation has revealed serious structural shortcomings: Excessive administrative burden, unpredictable certification timelines and requirements that often fail to reflect the actual risk profile of devices. As a result, Europe has become less attractive as a region to launch medical device innovation, which ultimately harms patients’ access to the latest technologies. The European Commission’s revision proposal seeks to address these consequences without reopening the MDR’s core safety objectives.  

Refocusing regulation on risk, not paperwork 

The legal proposal follows a clear red thread: To refocus the MDR on its original intention and direct regulatory scrutiny on genuinely higher-risk devices. This will stabilise a system that has buckled under its own weight. 

For EHIMA, this shift toward risk-proportionate regulation is essential. Hearing aids are classified as class IIa devices and have a well-established safety and performance profile. Yet under the current MDR, they have often been subject to onerous requirements designed for far higher-risk technologies. The revision begins to correct this imbalance. 

A particularly significant change is the proposal to abolish the automatic five-year re-certification cycle. Under the revised Article 56, certificates would remain valid indefinitely, unless objective grounds justify re-certification – for example, safety concerns or the need for additional post-market data. This targeted approach addresses one of the most resource-intensive bottlenecks in the current system. It allows devices with no known safety issues – e.g. hearing aids – to be continuously made available to users without interruptions from re-certification.  

Making clinical evidence requirements fit for purpose 

Clinical evidence remains a cornerstone of the MDR, and rightly so. But the revision recognises that here, too, the MDR has overshot on target: Established technologies with decades of safe use by millions of Europeans should not have to produce the same levels of evidence as breakthrough devices with no prior proof of concept. 

For the first time, a legal definition of “well-established technologies” (WETs) is created. Devices meeting strict cumulative criteria, including long market presence, stable design and absence of historical safety issues, would benefit from regulatory flexibilities, including exemption from clinical evaluation requirements. WETs will also face less paperwork: The scope of the “Summary of Safety and Clinical Performance” documentation and the frequency of Periodic Safety Update Reports will be greatly reduced. 

For EHIMA, recognition of WETs is a critical step towards a nimbler framework, which restores trust in manufacturers. It re-aligns regulatory effort with real-world risk. Hearing instruments, which represent standard-of-care solutions with decades of safe use, stand to benefit directly from this approach. 

Addressing the over-classification of medical device software 

The revision also tackles one of the most problematic aspects of the current MDR: the over-classification of medical device software. The proposed changes to Rule 11 would reclassify most medical device software as class I, except where it is linked to serious clinical decisions or a high risk of harm. 

Digital assistance systems are today a standard feature of many devices. They improve performance and convenience, but do not automatically entail safety risks to the patients. In hearing instruments, features such as sound processing, noise reduction or speech enhancement improve user experience but do not diagnose, treat or control physiological functions. Bringing classification in line with actual safety risks is essential to avoid stifling digital innovation in hearing care. 

The MDR also reduces overlapping compliance obligations with the European AI Act, which are already addressed under the MDR. 

Cybersecurity, meanwhile, is explicitly embedded into general safety and performance requirements, alongside a future obligation to report cybersecurity incidents. EHIMA supports this integrated approach, provided that implementation remains coherent and aligned with existing MDR processes. 

A necessary correction – but implementation will matter 

For the hearing health industry, the MDR revision proposal addresses many of the structural issues that have haunted the EU’s innovation ecosystem for the past year: Out-of-touch compliance with a device’s real-world risk profile, overlapping and conflicting design requirements, high compliance costs, and unpredictable time-to-market. The shift toward risk-proportionate regulation, recognition of well-established technologies and reduced re-certification pressure are particularly relevant for manufacturers of mature technologies such as hearing instruments. 

That said, the proposal is only the first step. As it will move through the European Parliament and the Council, careful attention will be needed to preserve its core objectives and avoid re-introducing complexity. 

A chance to restore balance 

The MDR revision represents a rare opportunity to restore balance to Europe’s medical device framework: Maintaining high safety standards while ensuring that regulation remains workable, predictable and innovation-friendly for the benefit of users. 

EHIMA stands ready to work with EU institutions and stakeholders throughout the legislative process to ensure that the final framework delivers on its promise – for patients, hearing care professionals and Europe’s hearing instrument industry alike.