Discover the new EU General Product Safety Regulation (GPSR) requirements effective 13 December 2024. Learn about the role of Responsible Person and Authorised Representative (EAR) to ensure product compliance in the EU market.
News
Distance sales devices: a look at EU requirements
Distance sales devices, sold through online platforms, must meet specific regulations outlined in Article 6 of the MDR and IVDR to ensure safety and performance. This includes devices used for remote healthcare services, even if not directly sold within the EU.
Mutual recognition of regulations between the EU and Switzerland
Discover how the EU and Switzerland maintain strong trade relations through mutual regulation agreements, enabling smoother market access for many products.
New Regulation for general products applies from December 2024
From 13 December 2024, the new EU General Product Safety Regulation (GPSR) applies, requiring stricter safety measures and a Responsible Person for all products.
26 September 2024: last call for manufacturers of legacy devices
Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.
Extended IVDR legacy period officially published
On 9 July 2024, the Official Journal of the EU published Regulation (EU) 2024/1860, amending the medical devices Regulations (MDR and IVDR). This introduces an extended legacy period for IVDs, effective immediately.
How to carry out clinical investigations of medical devices in the EU
To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.
New Toy Safety Regulation and the Digital Product Passport: upcoming changes for the toy industry
The update aims to address shortcomings in protecting children from toy-related risks, notably concerning hazardous chemicals.
The RP Mandate: an essential document for cosmetic compliance
The EU Cosmetics Regulation establishes that only products for which a legal or natural person is designated within the European Union as Responsible Person (RP) can be placed on the market.
European Parliament votes in favour of new IVDR legacy period and EUDAMED roll-out plan
Stay informed on upcoming cosmetic regulatory changes. Learn about the deadlines and new requirements for compliance in 2024.