The MHRA's November 2024 consultation: international reliance, UKCA marking, IVD classification and assimilated EU law.
Read MoreHow UKCA and CE marking work for importers, and what an importer service does for you.
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 MoreThe UK's proposed post-market surveillance rules: tighter reporting of adverse events and safety data.
Read MoreMHRA guidance on the UK Medical Devices Regulations 2002 for Great Britain: what the rules require.
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