24.03.2026 // Position Paper
MDR and IVDR: Simplification Without Compromising Safety
... The TÜV Association welcomes the planned revision of the MDR and IVDR. Positive elements include exemptions for orphan and breakthrough devices as well as stronger exchange between notified bodies. ...
#position#eu single market#medical products
11.03.2026 // Position Paper
Open Letter: Uniform AI regulations in Europe ensure innovation, security, and competitiveness
... The TÜV Association is a co-signatory of an open letter warning against planned changes as part of the EU’s “Digital Omnibus.” At the heart of the concern is the possibility that high-risk products ...
#ai#digitalization#eu single market#medical products
26.01.2026 // Position Paper
Commission Draft on MDR/IVDR: TÜV Association and IG-NB Highlight Practical Concerns
... In a joint position, TÜV Association and IG-NB welcome the European Commission’s objective to establish harmonised requirements for Notified Bodies under MDR and IVDR through a new Implementing ...
#position#medical products
16.12.2024 // Position Paper
MDR and IVDR Reform: TÜV Association Advocates for Reduced Bureaucracy and Enhanced Patient Safety
... On December 3, 2024, the EPSCO Council discussed a joint position paper by nine EU member states on necessary reforms to the MDR and IVDR regulations. The TÜV Association has provided its perspective ...
#position#eu single market#medical products#products
11.09.2024 // Position Paper
MDR and IVDR: End regulatory overload, maintain high protection level
... Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) came into force on 26 May 2017 and replaced the three directives (MDD, ...
#position#ai#eu single market#medical products
27.01.2023 // Press
Safe AI in medicine: TÜV Association becomes project partner at TEF-Health
... Berlin, 27. Januar 2023 – The TÜV Association becomes a partner of the "EU TEF-Health Project". TEF-Health stands for "Testing and Experimentation Facility for Health AI and Robotics" (tefhealth.eu). ...
#medical products#ai lab
25.03.2019 // Position Paper
Fast and uniform implementation of the new Regulations on medical devices
... Medical devices make an essential contribution to healthcare for the benefit of all patients. They are fundamental for the diagnosis, treatment, prevention, and monitoring of diseases. Medical ...
#position#european elections#medical products