European Commission in preparations of the MDR and IVDR regulations revision

The European Commission has launched a review of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The aim is to reduce the administrative and financial burden, which in practice mainly affects smaller manufacturers and hinders innovation. The Czech Republic actively participated in the consultations and sent its comments and suggestions for improvement to Brussels. Professional organizations – CzechMed, the Czech Association of Manufacturers and Suppliers of In Vitro Diagnostics, the Chamber of Dental Technicians, and the consulting company Porta Medica – also participated in the public consultation, which ran until October 6, 2025.

The current rules according to Member States bring a number of problems. These include the overload of notified bodies, long certification periods and inconsistent interpretation of requirements, as well as the delayed launch of the Europe-wide Eudamed database, which is intended to provide an overview of all devices on the market. The regulations place unreasonable demands on low-risk devices and require new evidence even for established products. These conditions are often difficult for small manufacturers to meet. The absence of a fast-track procedure for innovative devices and inconsistency with other EU rules have also been criticized.

Czech approach and suggestions for improvement

Czechia is one of the active states that participated in the evaluation. Joint comments were submitted by the Ministry of Health, the State Institute for Drug Control, and the Ministry of Industry and Trade. "The Medical Devices Regulation has strengthened patient safety, but at the same time has created a heavy administrative and financial burden. This slows down the availability of innovations and disproportionately affects small and medium-sized enterprises – the backbone of the European MedTech sector," states the Czech opinion.

Czechia proposes binding EU guidelines for uniform interpretation of rules, a central helpdesk for manufacturers, and improved functionality of the Eudamed database. It also recommends a faster approval process for innovative and rare devices with proportional evidence requirements and post-market inspections. According to the Ministry of Industry and Trade, the aim of the proposals is to reduce bureaucracy, strengthen innovation, and increase the competitiveness of Czech companies. The Ministry of Health adds that the changes must maintain a high level of patient safety while removing barriers that hinder innovation.

The EC plans to publish a draft amendment to the MDR and IVDR regulations at the end of 2025, after which it will undergo the standard legislative process, which can take one to three years depending on the scope of the changes and political consensus. At the same time, there is discussion that changes relating to notified bodies could be adopted under an accelerated procedure. Czechia expects that the planned revision will lead to simplification and clarification of the rules, elimination of duplicities, and creation of a more favorable environment for innovation and competitiveness, while maintaining a high level of patient safety.

Author: Markéta Hrubá