Written by the European Hearing Instrument Manufacturers Association EHIMA
Earlier this year, EHIMA welcomed the European Commission’s proposal to revise the Medical Devices Regulation (MDR) as an important opportunity to fix Europe’s regulatory framework. Bringing regulatory focus back to genuine risk profile of a device will make the certification system supportive of innovation without reducing Europe’s high standards of patient safety.
The legislative process has since moved forward. Following SANT Committee Rapporteur Oliver Schenk’s draft report on 30 June, Members of the European Parliament (MEPs) tabled their amendments on 28 July.
EHIMA welcomes the continued focus on reducing unnecessary regulatory burden to make conformity assessment more consistent and reduce duplication across the regulatory pathway. We encourage MEPs to keep up the momentum and resist backsliding on some changes that could have the greatest impact on the hearing instrument manufacturing industry. These include well-established technologies, the five-year validity period for certificates and the relationship between the MDR and the AI Act.
Greater consistency between notified bodies would be an important step
We are encouraged by MEPs’ strong support for more consistent conformity assessment. Notified bodies play a central role in assessing medical devices’ technical conformity and safety. But where assessments are repeated unnecessarily without a change in the underlying data or requirements are interpreted differently, manufacturers face additional work with no additional benefit for patient safety. EHIMA supports “regulatory reliance”, i.e. systematically respecting assessments that have already been performed, including assessments by other notified bodies. We also support reliance on internationally recognised quality management schemes such as ISO 13485 and the Medical Device Single Audit Program. We look forward to closer alignment by the European Commission and the Medical Device Coordination Group with international peers, including the United States Food and Drug Administration.
Keeping well-established technologies (WET) at the heart of the revision
The European Commission proposal introduced horizontal criteria (instead of a fixed list of devices) that could be used to determine whether a technology qualifies as ‘well-established’. A technology that is relatively new today may accumulate years of clinical evidence, market experience and safety data. A criteria-based approach allows the regulatory framework to recognise that development.
Many hearing instruments build on mature technologies supported by extensive clinical experience and long histories of safe use. Those products continue to evolve as manufacturers improve their software, connectivity, sound processing and other functionalities.
A well-designed WET framework is needed to recognise when the evidence surrounding a technology is sufficiently established to justify more proportionate evidentiary requirements. This does not remove the obligation to demonstrate safety and performance. Instead, it allows the nature and extent of the evidence required to reflect what is already known.
For EHIMA, codifying clear and objective criteria for well-established technologies is therefore an important part of making the MDR genuinely risk-based. Returning to a restrictive closed list would limit that opportunity and make the framework less able to respond as technologies mature.
Certificate validity should also reflect actual risk
EHIMA supports removing the current five-year maximum validity period for MDR certificates. Regulatory oversight should be driven by evidence and risk rather than by the passage of time alone.
The MDR already requires manufacturers to monitor their devices throughout their lifetime. Post market surveillance, vigilance, quality management and ongoing oversight by notified bodies provide mechanisms to identify new risks or changes in device performance.
Where a device continues to be safe and performing as intended, automatically repeating a comprehensive certification exercise does not necessarily provide additional protection for patients. It can instead consume capacity from manufacturers and notified bodies that could be directed towards products or developments requiring closer scrutiny.
Removing the automatic five-year validity period should therefore remain a core element of the revision.
The MDR and AI Act need one coherent regulatory pathway
The relationship between the MDR and the AI Act is equally important for the hearing instrument industry. Artificial intelligence and advanced software are increasingly integrated into medical technology. Modern hearing instruments already use sophisticated algorithms to improve speech understanding, reduce unwanted noise and adapt to different acoustic environments.
EHIMA supports appropriate safeguards for these technologies. At the same time, manufacturers should not be required to navigate two overlapping regulatory pathways where the same product, risks and requirements are already being assessed.
Hearing instruments are already subject to extensive requirements under the MDR, including risk management, software lifecycle processes, cybersecurity, post market surveillance and conformity assessment. Where relevant AI requirements need to be reflected in the medical device framework, they should be incorporated in a way that preserves appropriate safeguards without creating parallel assessments.
This is why Recital 23 is important. The MDR revision should ensure that the MDR and AI Act work together coherently and prevent separate or additional conformity assessment obligations where the same requirements are already addressed.
We expect the upcoming and amended Commission guidelines on high-risk AI systems to provide useful additional clarity for hearing instruments. However, guidance should complement a coherent legislative framework rather than compensate for uncertainty between two overlapping regulatory regimes.
EHIMA calls the European Parliament to deliver on the original objective of the MDR revision
The MDR revision is an opportunity to create a regulatory framework that is more proportionate, predictable and efficient while maintaining high standards of patient safety.
EHIMA therefore calls on the European Parliament and the SANT Committee to preserve a criteria-based framework for well-established technologies, remove the automatic five-year certificate validity period and maintain Recital 23 and its principle of avoiding overlapping obligations and conformity assessments between the MDR and the AI Act.
Together with greater regulatory reliance between notified bodies and closer international alignment, these measures would allow regulatory resources to focus where they provide the greatest benefit for patient safety.
For hearing instrument manufacturers, a more coherent and proportionate MDR is essential to continue developing safe and innovative technologies for people with hearing loss. The revision should retain the elements needed to make that objective a reality.
