PPWR has applied since 12 August 2026. What packaging manufacturers need now, the medical device exemptions, and Northern Ireland and GB.
Read MoreISO 9001:2026 replaces the 2015 edition and the 2024 climate amendment. What changed, what did not, and what an auditor will ask for.
Read MoreNotified bodies and data protection officers ask different questions of the same device. Where the health data sits, and what to do about it.
Read MoreEUDAMED's first four modules become mandatory on 28 May 2026. What manufacturers, authorised representatives and importers must do now.
Read MoreThe second edition of ISO 20417, published 17 March 2026, replaces the 2021 version. The labelling and information changes to plan for.
Read MoreClass C IVDs — companion diagnostics, cancer screening, genetic tests — face the May 2026 IVDR deadline. Are you ready?
Read MoreThe Commission's proposal COM(2025) 1023 to amend the MDR and IVDR: what it changes and what it means for manufacturers.
Read MoreThe amendment to EN ISO 14001:2015, due February 2025, brings climate change into environmental management systems.
Read MoreThe GPSR looks past B2C versus B2B: consumer safety across the whole supply chain, whatever the product's first intended use.
Read MoreThe 2026 revision of ISO 9001 was expected to address modern business challenges. What was proposed.
Read MoreThe EU has extended transition periods for legacy IVDs. The new dates, the conditions, and what to do to keep market access.
Read MoreThe MHRA's November 2024 consultation: international reliance, UKCA marking, IVD classification and assimilated EU law.
Read MoreEUDAMED's phased rollout from 2025: what each module means for manufacturers, and how to prepare.
Read MoreMDCG 2024-11 clarifies when a product qualifies as an IVD under the IVDR. The key points.
Read MoreThe European Parliament's push to overhaul the MDR and IVDR: what is on the table and why.
Read MoreHow UKCA and CE marking work for importers, and what an importer service does for you.
Read MoreWhere the MDR, IVDR and UK MDR transition deadlines stand after the extensions, and what still applies.
Read MoreHow to write a Declaration of Conformity for a medical device or IVD entering the UK market.
Read MoreThe documents a UK Responsible Person needs to register your devices with the MHRA.
Read MoreWhat a UK Responsible Person is, who needs one, and what the role covers.
Read More