ISO 13485 is the international quality management standard specific to the medical devices industry. It is a regulatory requirement for medical device manufacturers, importers and distributors operating in the UK and EU markets — and a commercial prerequisite for supply into NHS procurement and hospital supply chains.
Who needs ISO 13485?
- Medical device manufacturers placing products on the UK market
- Importers and distributors in the UK medical devices supply chain
- Contract manufacturers supplying CE-marked or UKCA-marked device manufacturers
- NHS supply-chain suppliers in medical equipment and devices categories
ISO 13485 and UK medical device regulations
Following the UK's departure from the EU, medical devices placed on the UK market are regulated by the MHRA under the UK Medical Devices Regulations 2002 (as amended). ISO 13485 certification is a recognised route to demonstrating compliance with quality management requirements under these regulations and supports compliance with EU MDR 2017/745.
How much does ISO 13485 certification cost?
ISO 13485 audits are more intensive than ISO 9001 due to regulatory complexity and sector-specific requirements. Contact UniCert for a tailored quote based on your product scope, regulatory classification and organisation size.
