Focus on MDR and IVDR: European Commission Launches Call for Evidence

The European Commission is planning to simplify the regulations governing medical devices and in vitro diagnostics. The aim is to promote the availability of safe and innovative products while ensuring a high level of patient safety and public health protection. Economic operators in the healthcare sector are now invited to participate in a consultation on this initiative.

Practical Challenges Due to Current Regulatory Requirements 

Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) have only been in effect for a few years. They introduce significantly stricter regulatory requirements, which have resulted in a considerable additional burden, particularly for medical device manufacturers. One of the main issues is the insufficient capacity of Notified Bodies. Since implementation difficulties became apparent from the outset, the transitional periods for both regulations have been extended several times. Currently, these periods end between 2027 and 2029, depending on the product category. There is particular concern about the risk of shortages or the withdrawal of important products from the market. A revision of the regulations has been called for not only by numerous stakeholders but also by the European Parliament and several Member States.

Call for Evidence Launched

The European Commission has initiated the revision process for the MDR and IVDR by collecting targeted assessments of both regulations. Building on the results of a consultation conducted at the beginning of 2025, the existing regulations will now be comprehensively evaluated and adjusted. Since 8 September 2025, stakeholders have had the opportunity to submit comments via the European Commission’s website. The call is directed especially at economic operators in the medical devices sector, including small and medium-sized enterprises („SME“). In addition to this survey, the Commission plans further targeted consultations, such as surveys and workshops. 

Objective of the Initiative 

The evaluation is intended to result in a proposal for a revised regulation. The goal is to streamline the existing legal framework, particularly by reducing administrative burdens. This is intended to strengthen the competitiveness of the European medical devices sector both in the internal market and internationally. At the same time, the initiative aims to specifically promote innovation, reduce strategic dependencies and make product safety requirements more cost-efficient and proportionate. The fundamental structure of the current legal framework is to be maintained. 

To achieve these objectives, the initiative focuses on the following points:

• Reducing administrative burdens, including reporting obligations
• Increasing predictability and cost-efficiency in the procedures for certification by Notified Bodies
• More proportionate requirements for conformity assessment, especially for products with low and medium risk and for products that meet specific patient needs
• Promoting digitalization
• Better alignment with other relevant legal provisions.

Opportunity for Active Participation 

Medical device manufacturers and other stakeholders now have the opportunity to actively participate in the European Commission’s initiative to revise the MDR and IVDR. The ongoing consultation can be used to provide concrete feedback on current challenges and suggestions for improvement regarding the two regulations. The deadline for submitting comments is 6 October 2025.