The TÜV Association regularly publishes positions and statements on current legislative projects on a national and European level. Here you can find an overview.
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 ...
#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, ...
#eu single market#ai#medical products
19.10.2023 // Position Paper
EU Commission proposal for a Toy Safety Regulation
... The main objective of the Toy Safety Directive is to ensure a high level of safety with a view to ensuring the health and safety of children. Looking at the notifications in the Safety Gate for ...
#position#product safety#toys
12.05.2021 // Position Paper
Toy Safety in the EU: not a Success Story
... Since 2009 the so-called Toy Safety Directive has been in force in Europe. The directive sets out all the requirements for toys that are to be placed on the market in Europe. This includes ...
#position#eu single market#product safety#toys
23.02.2021 // Position Paper
Conformity Assessment: Remote Activities
... In the field of conformity assessment, remote activities comprise all activities that take place without the physical presence of the subject of the conformity assessment. They are carried out with ...
#position#conformity assessment#accreditation
25.03.2019 // Position Paper
Safe and compliant products through independent assessment
... he Single Market is the backbone of the European Union and stands for the free movement of goods and services. EU-wide harmonisation of legal regulations for placing products on the market provides ...
#position#european elections#eu single market#product safety
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
25.03.2019 // Position Paper
Maintain high product standards and ensure open market access on fair competitive terms
... Products traded within the Single Market and worldwide must fulfil the applicable legal requirements and standards, i.e. they must conform and, first and foremost, be safe. Independent assessment ...
#position#european elections#eu single market