BSI Transitions

Learn about the MDR, IVDR, ISO 13485:2016 and MDSAP on our dedicated revisions pages.

Transfer to BSI

Transfer to BSI and start making excellence a habit in your business

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Recruitment opportunities

BSI is recruiting for medical device experts

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MDR and IVDR Critical Update:

BSI has submitted designation applications for the Medical Devices Regulation (Regulation (EU) 2017/745) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746) to both the UK and The Netherlands Competent Authorities. 26 November 2017 was the first day that Notified Bodies were allowed to apply for designation under the MDR and IVDR, BSI were among the first wave of Notified Bodies to submit for both Regulations. The next step is for the Designating Authority, MHRA in the UK and IGJ in The Netherlands, to review our application and write a preliminary report to be sent to the Commission so that they can schedule Joint Assessment audits of BSI.

BSI is proud to work towards designation for these critical Regulations and will continue to strive for excellence in our Notified Body activities over the transition period. We will ensure that you are kept up to date with the progression going forward.

Supporting your medical device business

Our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications – The BSI Medical Device Mission.

As a medical device manufacturer, there are a number of regulatory requirements you must meet before you can sell your devices on the international market. It is essential that your certification body has the capability and expertise to support you with robust product and system certification reviews, to ensure patient and user safety.

Maintaining quality, delivering excellence

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

A designated European Notified 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

Find out more about all of our services.

Our commitment to excellence

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.

We demonstrate this commitment through:

Over 2,050 years’ medical device product and regulatory experience
Internal Product Experts and Auditors
Direct access to your team of technical specialists
Our range of review services to give you flexibility

Support throughout the product lifecycle

Regardless of which phase of the product lifecycle you’re in, BSI can work with you to minimise your corporate risk and ensure you remain compliant.

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

How BSI can support you through the product lifecycle
Transferring to BSI
Our expert teams
Additional guidance and other resources
Access medical device standards
Training with BSI