Transfer to BSI

Transfer to BSI

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Transfer to BSI
Transfer to BSI
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Seamless service to BSI transfer

We understand that having confidence in your Notified Body and Approved Body to deliver an efficient and robust CE marking and UKCA marking, and a thorough Quality Management System assessment process is important. Our approach focuses on open communication from the very beginning, and your application will be supported by a dedicated team of medical device experts.

We can offer a seamless service with comprehensive support and the absolute minimum level of disruption.

What is the CE marking transfer process?

1. Your initial application

2. Pre-transfer initial documentation review

3. Pre-transfer Technical Documentation and QMS review, as needed:
    • Onsite QMS review
    • MDR/IVDR/UK Regulation Technical Documentation review

4. Recommendation for acceptance of transfer:
    • Certification Panel review
    • Contact previous Notified Body/Approved Body
    • Labelling transition

5. Transfer completion

Transferring your ISO 13485 certification

If you are transferring your ISO 13485 certification to BSI, we will conduct a Pre-Transfer Review to assess your organization, current certification and compliance.

  1. Pre-Certification Gap Analysis (optional)
  2. Pre-Transfer Review
  3. Certification Review
  4. Certification decision
  5. Certificate awarded
  6. Continuous Audit Visit cycle resumes

Benefits of choosing BSI

24 of the world’s top 25 global medical device manufacturers choose BSI as their Notified Body and UK Approved Body to provide CE and UKCA marking certification under EU and UK legislation.

In addition to a wide range of supporting resources to help you navigating the highly regulated MedTech sector, we offer:

  • Internal product experts and auditors
  • BSI Medical Devices has a team of more than 750; our technical experts have experience encompassing the full range of medical devices and management system standards
  • Full-scope Notified Body and Approved Body providing conformity assessments under the applicable European and UK legislation
  • Single technical point of contact
  • Responsive and robust conformity assessments