Brussels, 9 July 2026 — TIC Council, the global association of the testing, inspection and certification (TIC) sector, has today co-signed an open letter to Members of the European Parliament and representatives of the Member States in the Council, together with TÜV-Verband e.V., TEAM NB and the German Notified Bodies Alliance (IG-NB), ahead of deliberations on the revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
TIC Council supports the European Commission's objective of simplifying the rules and reducing unnecessary administrative burden. But, simplification must not come at the expense of the checks and balances that help medical devices safe, effective, and reliable for patients and healthcare professionals.
The open letter makes three calls to co-legislators:
Preserve the precautionary principle. Clear clinical requirements, technical documentation assessments, regular assessments and unannounced manufacturer audits are essential to identify risks before harm occurs — particularly for high-risk devices, where “well-established” must not be equated with “risk-free”.
Maintain regular oversight. Disproportionately lowering product requirements and weakening surveillance would increase the risk of unsafe or lower-quality products entering the European market, penalising manufacturers who invest in quality and evidence, and open the door to competition based on the lowest level of safety.
Keep AI-based medical devices within the AI Act. Removing the MDR and IVDR from the direct scope of the AI Act would create regulatory gaps and legal uncertainty. The right response to overlaps is intelligent integration of the two frameworks through clear guidance, coherent procedures and a single conformity assessment path for AI-based medical devices.
“TIC is the sector of trust,” said Naozad Hodiwala, Europe Executive Director of TIC Council. “Our role is to help turn regulatory requirements into real-world confidence for patients, clinicians and manufacturers. Europe should simplify and harmonize its medical device rules, but it must not do so by lowering the bar on safety, evidence or oversight.”
The full open letter is available here.
About TIC Council
TIC Council is the global trade association representing the independent third-party Testing, Inspection and Certification (TIC) industry which brings together about 100-member companies and organizations from around the world to speak with one voice. Its members provide services across a wide range of sectors: consumer products, medical devices, petroleum, mining and metals, food, and agriculture among others. Through provision of these services, TIC Council members assure that not only regulatory requirements are met, but also that reliability, economic value, and sustainability are enhanced. TIC Council’s members are present in more than 160 countries and the wider TIC sector currently employs more than 1 million people across the globe.
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