New EU rules: more business predictability and transparency in medtech conformity assessment

Brussels, 07 May 2026 - Europe's conformity assessment system has long been criticised for unpredictability, inconsistency, and administrative burden. The European Commission's Implementing Regulation (EU) 2026/977 of 4 May 2026 aims to address that directly by laying down uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body.

MedTech Europe welcomes it as a meaningful response to longstanding concerns raised by the medical technology sector and as an important short-term measure while the broader revision of the MDR and IVDR remains the ultimate priority.

MedTech Europe has consistently called for greater predictability and transparency in conformity assessment, including through sustained engagement with regulators and notified bodies. The Implementing Regulation reflects a number of the principles we have advocated for: defined timelines, reduced administrative burden, and stronger safeguards for manufacturers.

Oliver Bisazza, CEO of MedTech Europe: "This is a meaningful first step towards a more predictable and consistent system. What matters now is implementation. We need to ensure that these rules translate into real improvements on the ground - faster, more transparent and more efficient conformity assessment for manufacturers and patients alike."

What the Implementing Regulation introduces:

• Clearer conformity assessment timelines. The Regulation sets defined maximum timelines and strengthened procedures for key assessment phases, including application review, product assessment and certification decisions. Manufacturers will have clearer visibility on timelines and costs when planning certification.

• Reduced administrative burden. Notified bodies will be required to provide estimated timelines at quotation stage. Manufacturers will no longer need to resubmit unchanged information for repeat procedures, cutting duplicative paperwork and improving efficiency.

• Safeguards against procedural refusals. Assessments must be completed on their merits and cannot be refused solely on procedural grounds, such as expired timelines or the use of interruption mechanisms.

• Greater predictability for investment and innovation. More consistent and transparent procedures will help companies - particularly SMEs - plan investments, innovation pipelines and market-entry strategies with greater confidence, strengthening European competitiveness and supporting timely patient access to medical technologies.

MedTech Europe urges consistent EU-wide implementation of these rules and stands ready to work with the European Commission, Member States and notified bodies to ensure real benefits for manufacturers, healthcare systems and patients.

This Implementing Regulation is a complementary and necessary stabilisation measure, sitting alongside the ongoing targeted revision of the MDR and IVDR currently under discussion in the European Parliament and the Council. The revision addresses structural issues in the regulatory framework; the Implementing Regulation addresses how conformity assessment operates within it today. Both are needed, and neither is sufficient on its own. For further information on MedTech Europe's views on the MDR/IVDR revision, read our full position here.

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About MedTech Europe

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions.

www.medtecheurope.org.

For more information, please contact:

Davidson Leite,

Director Communications

[email protected]