EU Launches Evidence on Targeted Revision of MDR and IVDR 

The European Commission has launched a Call for Evidence on the planned targeted revision of the Medical Device Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR, EU 2017/746). 

Since their adoption, the MDR (applicable since May 2021) and IVDR (applicable since May 2022) have faced significant implementation challenges. Limited notified body capacity, demanding requirements, and insufficient preparedness among manufacturers have led to risks of device shortages and withdrawal of critical products from the EU market. 

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Key Implementation Challenges

To address these issues, the Commission is preparing a proposal for a Regulation (expected Q4 2025) aimed at: 

• Reducing administrative burden and reporting obligations. 

• Enhancing predictability and efficiency of notified body certification processes. 

• Introducing more proportionate requirements for low- and medium-risk devices. 

• Supporting digitalisation and improved governance. 

• Strengthening international cooperation and regulatory alignment. 

• Better integrating MDR/IVDR with other EU legislation. 

The initiative will simplify the framework while safeguarding high levels of patient safety and public health. Unlike previous transitional extensions, this revision seeks long-term solutions to ensure predictability, competitiveness, and innovation in the EU medical device sector. 

Stakeholder Input & Timeline 

• The Call for Evidence opened on 8 September 2025. 

• Stakeholders can provide feedback via the Have Your Say platform until 6 October 2025. 

• Input will be taken into account in preparing the Commission’s proposal and the accompanying staff working document, which will set out the evidence base, analysis, and expected impacts. 

• Further targeted consultations (surveys, workshops, dedicated meetings) will follow, with a particular focus on the role of SMEs. 

Who Should Participate 

The consultation is open to: 

• Competent authorities, notified bodies, manufacturers, and other economic operators. 

• Healthcare professionals, patients, and consumer groups. 

• Civil society, academic and research experts, and the general public. 

For more details and to submit feedback before the deadline please find full details here: Medical devices and in vitro diagnostics – targeted revision of EU rules.

How Can MedEnvoy Support  

We actively monitor EU regulatory revisions such as MDR and IVDR regulations and support our clients in staying up to date with key changes, ensuring they remain compliant and informed every step of the way.

If you have questions about how these EU medical device reform changes affect your products – or need expert support to ensure continued compliance in the EU – MedEnvoy is here to help. We simplify regulatory complexity, helping you stay focused on innovation and patient outcomes.