Medical Devices

Our mission is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global standard in thorough, responsive, robust 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:

• A designated EU Notified Body
• A UK Approved Body
• An accredited ISO 13485 Certification Body
• A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP)
• A recognized Certification Body in many global markets

Supporting you throughout the product lifecycle

Regardless of which stage you are at, BSI can work with you to minimize your corporate risk and ensure you remain compliant.

Talk to us early to take advantage of our full range of services.

The Regulatory Services Division of BSI Group regretfully has had to make the decision to discontinue its services in Russia.

Learn more about BSI's Regulatory Services (Medical Devices) certification business policy, and our customer feedback policy and procedure.

As the coronavirus COVID-19 outbreak evolves, the safety and wellbeing of our clients and colleagues is our highest priority, so please read our latest updates on how we are managing global audits and assessments.

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.