3 docs tagged with "mhra"

Index of MHRA guidance documents for medical devices, organised by topic — covering classification, clinical evaluation, post-market surveillance, vigilance, software, IVDs, and the MHRA Submissions portal.

The powers MHRA can exercise to initiate safety actions independently of manufacturers — including suspension and prohibition notices, recall orders, public warnings, and enforcement under the UK MDR 2002.

A structured overview of the UK medical device regulatory framework — the MHRA, the UK MDR 2002, UKCA marking, UK Approved Bodies, the Northern Ireland dual-market position, and how the framework compares to the EU MDR/IVDR.