2026 has already been an important year for European health and technology policy. Across Brussels, a common theme has emerged: how can Europe maintain high standards of safety and protection while making its regulatory environment clearer, more proportionate and better suited to innovation?
For hearing care, this is more than an abstract policy discussion. Modern hearing instruments are sophisticated medical devices. They increasingly combine advanced sound processing with connectivity, software and artificial intelligence. The rules governing medical devices, AI and data therefore have a direct bearing on how hearing technology is developed and brought to people across Europe.
At the halfway point of 2026, several pieces of this regulatory picture have become clearer. Others remain very much a work in progress.
Europe is reopening its medical device rulebook – but one big question remains
At the centre of the debate for the hearing sector is the revision of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). These are the sector-specific rules governing medical devices in Europe, and their revision is one of the most important regulatory developments of 2026. The European Commission presented its proposal at the end of 2025, and both the European Parliament and EU Member States have spent the first half of this year examining it.
There is broad support for the overall objective: maintaining a robust framework for patient safety while making the system simpler and more predictable. In the European Parliament, lead lawmaker Oliver Schenk presented his draft report at the end of June, broadly supporting the Commission’s approach to regulatory simplification. His proposals will now be debated and amended as Parliament develops its negotiating position. Member States have also made substantial progress in reviewing the Commission proposal and broadly support its simplification objectives.
For hearing instrument manufacturers, one particularly important question is how these sector-specific rules should interact with the EU’s separate rules for artificial intelligence. The Commission has proposed integrating requirements for AI-enabled medical devices into the MDR framework to avoid overlapping regulatory processes. Schenk’s draft supports this approach, while Social Democrats and Greens have raised concerns about moving medical devices from the AI Act into the MDR framework. In the Council, several Member States also support avoiding overlapping requirements, but discussions on the issue are continuing.
For the hearing sector, getting this interaction right matters. Hearing instruments are already subject to extensive requirements under the MDR while increasingly incorporating sophisticated digital and AI-supported functions. In this regard, EHIMA supports a regulatory framework that maintains patient safety while ensuring that different EU rules work together coherently, avoiding unnecessary duplication and providing manufacturers with clear and predictable requirements.
How this question is resolved will be one of the key issues to watch in the second half of the year. Ireland, which assumed the rotating Presidency of the Council in July, has made the MDR/IVDR revision a priority and will continue negotiations among Member States. In the European Parliament, lawmakers will debate amendments and seek compromises around Schenk’s draft, as Parliament works towards its negotiating position around the end of 2026 or beginning of 2027.
For AI, the clock is settled – attention now turns to what counts as high-risk
While the MDR/IVDR revision is still being negotiated, a separate piece of the regulatory puzzle has become clearer. The EU has now completed its work on the AI Omnibus, which amended parts of the AI Act, including the timetable for its high-risk requirements.
Artificial intelligence is increasingly part of modern hearing technology, supporting functions such as sound processing, noise reduction and making speech easier to hear in challenging environments. As these technologies develop, an important question is how EU rules distinguish between different uses of AI and their respective risk profiles.
On timing, 2026 has brought greater certainty. The AI Omnibus was published in the Official Journal in July and fixes 2 August 2028 as the application date for the relevant high-risk AI requirements for products covered by Annex I, including medical devices.
The AI Omnibus therefore settled an important question of timing, but it did not resolve the more fundamental question of how AI in medical devices should be regulated. Medical devices remain in Section A of Annex I to the AI Act for now, leaving them within its high-risk product framework. As discussed above, however, the ongoing MDR/IVDR revision has reopened the question of whether relevant AI requirements for medical devices should instead be integrated into the sector-specific framework.
There is also another important layer to the issue: even while medical devices remain in Section A, not every AI function within a medical device will necessarily qualify as high-risk. Where that line is drawn matters considerably for hearing technology.
Commission guidance on the interpretation of the AI Act indicates that AI functions used for purposes such as performance optimisation, convenience or user assistance should generally not be considered safety components where their failure does not itself create a direct health or safety risk. This distinction is particularly relevant to hearing technology, where AI can be used to improve how a hearing instrument performs for its user without necessarily controlling a safety-critical function.
For EHIMA, the next phase is therefore also about implementation: ensuring that the rules recognise the different ways AI is used in medical technology and that requirements reflect the actual function and risk of an AI system, while maintaining appropriate safeguards where safety is at stake.
The bigger picture: simplifying Europe’s digital rulebook
The AI Omnibus itself sits within an even broader EU effort to simplify its growing body of digital regulation. Through the Digital Omnibus, the European Commission has sought to address areas where different digital rules overlap or create unnecessary complexity. The changes to the AI Act described above are one important part of that wider simplification agenda.
This matters for medical technologies because they increasingly sit at the intersection of several frameworks. Alongside the MDR and AI Act, connected medical devices can also be affected by EU rules covering areas such as data and cybersecurity.
EHIMA supports Europe’s ambition to build a trusted and innovative digital economy. At the same time, regulation works best when requirements are coherent, proportionate and clear.
The developments around the AI Act illustrate why this matters. Simplification cannot simply mean changing deadlines. For sectors such as medical technology, the more fundamental objective should be ensuring that different EU rules work together and that equivalent requirements do not have to be addressed repeatedly through separate regulatory processes. That same principle is now at the heart of the debate over the MDR/IVDR revision.
From regulation to competitiveness
These efforts are also part of a broader change in the political conversation. The first half of 2026 has demonstrated that Brussels increasingly sees better regulation and simplification as part of the wider challenge of strengthening Europe’s competitiveness.
In April, the European Parliament, Council and Commission signed the “One Europe, One Market” roadmap. It places regulatory simplification and deeper Single Market integration alongside trade, industrial policy, energy, decarbonisation and digital transformation as parts of a broader effort to strengthen Europe’s economy. Other initiatives have followed the same direction, including proposals addressing industrial policy and Europe’s technological capabilities.
For the hearing sector, the underlying issue is straightforward: Europe needs to remain a place where innovative medical technologies can be developed and made available while continuing to uphold high standards of patient safety.
These objectives should reinforce rather than contradict one another. Predictable regulation, internationally relevant standards and efficient regulatory processes can help support both patient protection and innovation.
What to watch in the second half of 2026
With the AI Omnibus now adopted, attention in the second half of 2026 will shift increasingly towards implementation of the AI Act and the legislative files that remain open.
The MDR/IVDR revision will remain particularly important. The European Parliament will continue working towards its position, while Member States will continue negotiations in the Council. As outlined above, the relationship between the MDR and AI Act will be one of the issues to follow closely. No final outcome should be assumed at this stage.
Several other important initiatives are scheduled as well. These include a Commission proposal on the revision of EU public procurement rules, expected in September; work on the New Legislative Framework, which underpins much EU product legislation; and the planned Circular Economy Act. An opinion from the European Chemicals Agency on the proposed restriction of PFAS is also expected in the fourth quarter.
Keeping the patient at the centre
If the first half of 2026 has demonstrated anything, it is that European policymaking is increasingly interconnected. The MDR/IVDR revision, AI Act and wider digital simplification agenda are separate initiatives, but the way they interact will help determine the regulatory environment in which the next generation of hearing technologies is developed.
For EHIMA, the objective remains clear: Europe needs rules that safeguard patients, provide certainty and enable continued innovation in hearing technology. Regulation should reflect the actual risks and characteristics of technologies, avoid unnecessary duplication and recognise the robust sector-specific framework that already applies to medical devices. The legislative discussions underway in 2026 provide an opportunity to move closer to that goal.
Ultimately, however, regulation is a means rather than an end. The measure of a successful framework is whether safe and effective technologies can continue to reach the people who need them. As Europe grows older and hearing health becomes an increasingly important public health consideration, keeping that objective in sight will be essential.
