Gain the market confidence you need to reach your goals.

BSI employs over 150 medical device experts with experience in all aspects of the product life cycle including research and development, manufacturing, and quality assurance.

Mitigate future risk and manage compliance – especially as your position in the global market shifts. BSI has multilateral agreements with many countries so that our test reports for a wide range of products can be accepted.


Maintaining quality, delivering excellence

BSI Medical Devices offers certification services to support your global market access goals. We are:

Find out more about all of our services.



EU Referendum Result

After Britain voted to leave the EU, BSI will continue to operate as an EU Notified Body.

Read our full statement to understand more about BSI's position.



New Medical Devices Regulation and IVD Regulation now published

The final texts of the new European Medical Devices Regulation (MDR) and IVD Regulation (IVDR) have been published in the Official Journal of the European Union. Entry into force will commence on May 25th, marking the start of the transition period for manufacturers selling medical devices into Europe.

The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. The IVDR, which replaces the IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

You can find more information on our dedicated revisions webpages:

MDR Revision

IVDR Revision


How BSI can support your medical device business

We understand the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.

Our commitment to excellence

Manufacturers tell us they need to work with a highly competent, customer focused Notified Body that understands the specifics of their environment and the importance of complete confidentiality around patent pending new technology.

Our services are designed to align with the steps individual clients need to take to understand what is best practice, how to achieve it and ensure that it remains an ongoing habit.

We provide rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too.



What are the benefits of ISO 13485 Medical Devices?

  • Increase access to more markets worldwide with ISO 13485 certification
  • Outline how to review and improve processes across your organisation
  • Increase efficiency, reduce costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations

Access to Global Markets

By working with BSI, medical device manufacturers are choosing to seamlessly access global in-house experts with regulatory experience in a wide-range of products and technical areas. Our experts have extensive hands-on experience in all aspects of the product life cycle including R&D, manufacturing and quality.

We are an approved “full scope” Notified Body recognized by the European Commission for 17 Directives and also hold recognition by FDA (US), CMDCAS (Canada), JPAL (Japan), ZLG/ZLS (Germany), and (Australia under MRA),Taiwan FDA (under TCP program), and HongKong MDCO (under HKCAB). We offer a results-focused portfolio of products and services for each stage of your certification journey, and we are committed to establishing long-term, proactive relationships with our customers.


Popular Medical Devices training courses

Design and develop medical devices to international quality standards, ensure smooth submission, meet ISO 13485 standards, satisfy customers and keep ahead of all regulatory developments with our medical devices training courses.