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
02.03.2026 // Position Paper
Effective Emissions Testing: Safeguarding the Credibility of European Environmental Policy
... In their joint position paper, TÜV Association, DEKRA and the ASA Association advocate for a consistent advancement of emissions testing within the European Roadworthiness Package. The objective is ...
#position#sustainability#mobility
12.02.2026 // Position Paper
Strengthening market surveillance – for fair competition and a high protection level
... The rapid growth of online trade, global supply chains and sharply increasing goods flows are pushing existing market surveillance systems to their limits. Despite significantly rising import ...
#position#eu single market
11.02.2026 // Position Paper
Digital Omnibus on AI: Implementing the AI Act in a Practical Manner
... Effective enforcement of the AI Act requires a sufficient number of competent conformity assessment bodies. Existing designations under sectoral product legislation should therefore be used as a ...
#position#ai#digitalization
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
05.09.2025 // Position Paper
Position on the Mutual Recognition Agreement (MRA)
... The EU and the US have issued a joint statement on a framework agreement for mutual, fair and balanced trade – a so-called Mutual Recognition Agreement (MRA). In Section 8 the agreement explicitly ...
#position#roadsafety#vehicle type approval
25.06.2025 // Position Paper
Feedback on the EU Commission proposal (COM(2025)258) as regards the postponement of battery due diligence obligations for economic operators
... With the fourth omnibus package (COM(2025)258), the European Commission is planning to postpone the start of the due diligence obligations for battery manufacturers and importers provideded in ...
#position#sustainability#eu single market
15.05.2025 // Position Paper
Shaping the New Legislative Framework for the future
... The European ‘New Legislative Framework’ (NLF) is the foundation for the product regulation in the European Single Market. However, in a time of technical innovations, global competition and growing ...
#position#eu single market#product safety#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