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
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
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
07.03.2025 // Announcement
Why the EU Parliament needs to improve the EU Action Plan for the Automotive Industry
... Berlin, 7. March 2025 - The European Commission's Industrial Action Plan for the European automotive sector (COM(2025) 95) sets important priorities for the European automotive industry, particularly ...
#eu single market#mobility
26.02.2025 // Press
EU Omnibus Package on Sustainability step in the right direction – but do not lose sight of its objectives
... Berlin, 26 February 2025 – With the first ‘omnibus package’ published today, the EU Commission is presenting a far-reaching proposal to simplify and harmonise existing corporate reporting obligations ...
#sustainability#eu single market#supply chains#csrd
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
23.06.2022 // Position Paper
Position Paper on the EU Commission's proposal for a new Ecodesign Regulation
... The Ecodesign Directive 2009/125/EC has already been able to continuously reduce negative environmental impacts of energy-related products, while ensuring a level playing field for companies in the ...
#position#sustainability#eu single market