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The European Commission has released a revised guideline (EGLA, dated 2 March 2026) clarifying the candidate laboratory alignment procedure under Annex V of Regulation (EU) 2020/740 — the EU Tyre Labelling Regulation.
The European Union has taken a major step toward harmonising how new medicines are evaluated across its member states, with the formal launch of Joint Clinical Assessments (JCAs) under Regulation (EU) 2021/2282 — the EU's Health Technology Assessment (HTA) Regulation
Learn how non‑EU manufacturers can avoid costly representative actions under Directive (EU) 2020/1828 by ensuring full EUDAMED and EPREL compliance. Expert guide to registration obligations, legal risk mitigation, and EU market access.
On December 4, 2025, the European Commission launched a new public consultation aimed at updating the energy labelling and ecodesign rules for household and commercial refrigeration appliances. These changes are part of the EU’s broader push for energy efficiency and sustainable product design — and they’re set to have a
EUDAMED, the European Database on Medical Devices, is the cornerstone of EU MDR compliance—mandated for all medical device manufacturers placing products on the EU market. For non-EU manufacturers, registration in EUDAMED is not optional. Gaining or maintaining market access requires registering as an economic operator and listing all devices in
For non-EU manufacturers entering the European market, compliance with EU energy labelling regulations (EPREL/ERP)—notably Regulation (EU) 2017/1369—is essential. This regulation mandates that all energy-related products must be registered in the European Product Registry for Energy Labelling (EPREL) prior to being marketed or sold in the EU.
Adopted on 13 June 2024 and published in the Official Journal of the European Union on 9 July 2024, Regulation (EU) 2024/1860 amends both the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746. A central change concerns EUDAMED — the European Database on Medical Devices
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