Our mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner. We strive to set the global standard through conducting impartial, responsive, robust and thorough conformity assessments, evaluations and certifications that are recognized and trusted worldwide.
BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.
Maintaining quality and delivering excellence
BSI Medical Devices offers certification services to support your global market access goals. We are:
BSI issues the first UKCA certificate for Medical Devices and IVDs
BSI issues its first UKCA certificate under the UK MDR 2002 legislation for medical devices via its newly designated UK Approved Body (0086). The first UKCA certificate covers theatre instrument sets.
You can check company, site and product certificates to validate the credentials or resources of a supplier or understand your competitor landscape. BSI’s directories will provide an extensive list of all current BSI certificates.