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Regulatory Services

Transfer Your Medical Device Certification to BSI with Confidence

Clarity at every stage. Continuity built in. A structured, transparent approach to transfer certification while minimizing disruption.

Supporting You

Helping you transfer certification with confidence, clarity and continuity

Transferring your medical device certification doesn’t have to mean starting again. Whether driven by portfolio alignment, organizational change or the need for greater certainty, you can transfer at any stage. BSI supports CE, UKCA and quality management system transfers through a structured, transparent approach, maintaining continuity of certification and audit programmes while reducing disruption and providing clear, predictable steps.

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What to Expect

A clear pathway from review to certification

Your transfer pathway will depend on your existing certification, device type and readiness to proceed. You can explore what information may be needed, how your current certification and audit programme may be considered, and what to expect as you move through application, review and certification.

Understanding your options for transferring to BSI

Explore why you might transfer and how BSI supports a smooth, confident transition.

Expert Teams

Transfer support by business sector

Transfer requirements vary by device type and technology. Explore how you can transfer certification across key medical device sectors.

You can transfer certification for active implantable medical devices to BSI through a structured and transparent process. Transfers reflect the additional safety, clinical and lifecycle considerations associated with AIMDs, with consideration of existing clinical, technical and post‑market assessments, supporting continuity while maintaining rigorous oversight.
You can transfer certification for active medical devices across a broad range of technologies and intended uses. Transfers are managed to support a smooth transition while addressing relevant technical and quality system considerations.
You can transfer certification across a wide range of general medical devices, covering different technologies and classifications. A structured approach helps maintain alignment with applicable regulatory and quality requirements.
You can transfer certification for in vitro diagnostic medical devices with support from experienced specialists. Transfer activities reflect the regulatory and conformity assessment requirements specific to IVD technologies.
You can transfer certification for devices incorporating medicinal substances or biologics, supported by specialist technical expertise where required. Transfers reflect the additional regulatory interfaces that may apply.
Transfer your microbiology or sterile medical device certification with a clear, structured approach across applicable certification routes. BSI helps you understand what is needed, reduce uncertainty and maintain continuity as you move forward.
You can transfer certification for orthopaedic and dental medical devices to BSI, taking into account existing clinical, technical and post‑market assessments. Transfers are designed to be efficient and to minimize disruption.
You can transfer certification for Software as a Medical Device, taking into account software development, maintenance and lifecycle requirements. Transfers also consider existing clinical, technical and post‑market assessments, supporting continuity while reflecting the evolving nature of digital health technologies.
You can transfer certification for vascular medical devices across a wide range of classifications and technologies. Transfers reflect the specific safety, performance and clinical requirements of vascular applications, with consideration of existing clinical, technical and post‑market assessments, supporting continuity while maintaining rigorous assessment standards.

Medical Devices

Choose the right certification transfer pathway

Select the certification transfer pathway most relevant to your organization to explore how BSI can support the transition.

CE certification transfer

Access structured support, including pre‑transfer reviews, transfer readiness guidance and certificate issuance.

CE transfers

UKCA certification transfer

Receive support through application review, technical assessment, engagement with your existing Approved Body and certification by BSI.

UKCA transfers

ISO 13485 and MDSAP transfer

Transfer ISO 13485 or MDSAP certification through verification assessment while maintaining continuity of your existing audit cycle.

ISO & MDSAP

Why transfer your certification to BSI

Clear, practical reasons to support confident, well‑informed transfer decisions:

Reduce operational disruption during transfer.
Gain a clear, predictable transfer process.
Access support at any stage of your regulatory journey.
Benefit from expertise across CE, UKCA and quality management systems.
Have confidence in transparent review and decision-making.
Maintain continuity beyond certificate issuance.

Our Approach

Our approach to transferring your certification to BSI

Our transfer approach is built on open communication, transparency, and predictability.

From the outset, you are supported by a dedicated team to confirm objectives, assess readiness and guide each stage of the process. Our approach is designed to minimize disruption while maintaining continuity of certification and audit programmes wherever possible.

Talk to us about your transfer options

Whether you are exploring a transfer or ready to proceed, our medical device experts can help you understand the right pathway for you.

Get in touch