EAAR 2026: Key EU Regulatory Developments

By Roxana Cernescu and Annette van Raamsdonk

Outlook on future regulations in the European Union 

The 10th annual European Association of Authorized Representatives (EAAR) conference took place Sept. 8-9, 2026, in Brussels, with Emergo by UL participating in the event’s organization. Speakers included Flora Giorio, head of unit for Medical Devices at the European Commission (EC), and Nada Alkhayat, an EC policy officer specializing in emerging technologies, including AI-enabled devices. Representatives from the EC, the Belgian Competent Authority (CA), the Federal Agency for Medicines and Health Products (FAMHP), Notified Bodies (NBs) and industry shared perspectives on key regulatory developments affecting the European medical device sector. Discussions focused on Implementing Regulation (EU) 2026/977, the proposed revisions to the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), efforts to simplify the EU regulatory framework, and updates on the European Database on Medical Devices (EUDAMED) and national registration requirements.

Simplification of the regulations 

While the panelists, including representatives from the EC, NBs and industry, agree on the need to reduce the regulatory burden in the EU while maintaining a high level of patient safety, their views on how to achieve this differ. 

NBs are concerned that reduced oversight of lower-risk-class devices and the decreased sampling and surveillance requirements may negatively affect patient safety and increase NB liability. They support a “risk-adaptive surveillance” approach that is performance-based and supports a life cycle approach. Sebastian Fischer described the concept as “rewarding sustained regulatory compliance and high-quality manufacturer performance while maintaining a preventive surveillance system.”

NBs do, however, welcome aspects of the proposals that would allow manufacturers to make greater use of NB expertise, including participation in expert panels, earlier structured dialogue with NBs and a formalized role for the NB Coordination Group (NBCG-MED).

Digitalization of the conformity assessment process and market surveillance

One of the pillars of the new proposals is to reduce the administrative burden and harmonize NB assessments. For example, the proposal enables NBs to perform remote conformity assessments. In the meantime, while stakeholders are waiting for the proposals to be adopted, they are already working on further digitalization. 

This month, the European Horizon Project DIGICAP launched with a main goal of creating formats for structured machine-readable data and data exchange. This goal should lead to more harmonized and efficient conformity assessments for manufacturers and NBs. Contributors include competent authorities of member states, the EC, NBs and industry representatives.

Aside from digitalization, the EC is looking into best practices from other jurisdictions and international cooperation and is assessing how it can make a more resilient and adaptable legal framework. Such a framework will, for example, allow regulators to adopt implementing regulations or binding common specifications when necessary. The EC is currently working on setting up a horizon scanning system for medical devices and in vitro diagnostic devices (IVDs) to maintain an up-to-date overview of new and emerging technologies. 

Finally, the FAMHP shared insights from inspections of Authorized Representatives (ARs) located in Belgium, which related to, among other things, incomplete mandates and lack of access to manufacturers’ technical documentation. Additionally, the FAMHP shared how CAs from different member states perform joint inspections. 

An EU-wide pilot on Reinforced Market Surveillance of Medical Devices and In Vitro Medical Devices (JAMS 2.0) will come to an end this year. The aim of JAMS 2.0 is to harmonize the way CA inspections take place and to create common guidelines and templates.

Clinical evaluations and investigations

Growing evidence demands under the MDR are slowing innovation and device access, while traditional trials remain costly and time-intensive. In silico methods offer scalable, efficient alternatives but require further regulatory acceptance to achieve widespread impact. Nevertheless, under the current regulations, these methods are not accepted.

Overall, current MDR clinical evidence demands are expanding in complexity and scope, requiring adaptive strategies, stronger infrastructure and innovative methodologies to balance regulatory compliance with timely patient access and sustainable innovation.

Under the proposals, the definition of clinical data is expanded, allowing manufacturers to use in silico models, other new approach methodologies and possibly studies performed outside the EU that did not follow Article 62. Additionally, the definition of biological and clinical equivalence is broadened, allowing more manufacturers to follow a simplified conformity assessment route and avoid the need to conduct a clinical investigation. 

The new ISO 18969:2025 Clinical Evaluation process for medical devices is still under development. The Final Draft International Standard (FDIS) was published. It will be the first science-based, worldwide applicable standard for clinical evaluations. It is expected to be harmonized as a European standard. The standard will be supplemented by a new Medical Device Coordination Group (MDCG) guidance document that will replace MEDDEV 2.7/1. The draft was developed by ISO/TC 194 and is nearing finalization. It is expected to be published in 2026.

For IVD manufacturers, the draft IVDR proposal, as well as the new Biotech Act, could simplify certain regulatory processes. The Biotech Act aims to streamline and simplify, for example, clinical trials taking place in multiple countries, facilitate the use of AI, data and digital solutions, and decrease the time to market.

EUDAMED and vigilance

EUDAMED aims to enhance overall transparency, including better access to information for the public and healthcare professionals and to enhance coordination among the different member states in the EU. A member of the IT project management team involved with the implementation of EUDAMED reported their experience with the database. As of May 28, 2026, four modules — EO, Devices/UDI, NB and Certificates, and Market Surveillance — of the six became mandatory. The transition occurred without significant system disruptions despite increased data traffic.

The next important deadline will be Nov. 28, 2026, when all legacy devices must be registered in EUDAMED. For the remaining two modules, Post-Market Surveillance and Vigilance (PMSV) and CI/PS, the timeline indicates that the PMSV module is currently being audited. Emergo by UL helped with testing of this module in collaboration with member states and a manufacturer. The current estimate for publication in the Official Journal of the European Union (OJEU) is Q4 2026, though this is subject to change. In any case, six months after the publication, use will become mandatory. Training material is available in EUDAMED’s Information Center. The CI/PS module is still being analyzed and developed; a publication date has not yet been identified.

Conclusion 

The conference highlighted ongoing discussions regarding the future direction of EU medical device regulation and provided an opportunity for engagement among clients, the EC, NBs and other stakeholders. While it will still be some time before the draft proposals are adopted, the proposed changes are intended to support a more transparent and predictable regulatory framework for innovative devices in the EU.

Emergo by UL will continue to monitor regulatory developments and support manufacturers operating in the European market.