The ISO 13485 for Medical Devices standard is voluntary, but many governments around the world including in the UK, make it a legal requirement to comply with the MDD.


The US FDA has also said that ISO 13485 is the “minimum standard for a quality management system.”


ISO 13485 implementation covers the guidance of:


International Medical Device Regulators Forum (IMDRF) including those documents maintained from the disbanded Global Harmonization Task Force (GHTF);
International Organization for Standardization (ISO);
European Committees for Standardization (CEN and CENELEC);
National regulatory bodies.

Companies must check with their regulatory body to see if the standard is a legal requirement in their respective country.