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Regulatory Services

How We Work With Our Medical Device Clients

BSI works with many of the largest medical device companies in the world.

What We Offer You

Maintaining quality and delivering excellence, BSI offers certification services to place safe and compliant medical devices on the market.

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

Regulatory Services

Combined Expertise and Solutions

Our regulatory services combined with our world-leading experience provide efficient pathways to place your device on the market.

Structured Dialogue offers manufacturers an opportunity to better understand the Notified Body conformity assessment processes for medical devices and IVDs. It's different from scientific advice, excludes the Notified Body providing solutions to the manufacturer and does not have any impact on future certification decisions for the device under application.

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We offer a wide range of resources to support SME's by increasing their knowledge on key regulatory topics for market readiness.

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BSI provides experienced and efficient routes to global markets.

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

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CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.

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BSI UK (0086) is a leading full-scope Approved Body under the UK MDR 2002, as amended. We review your medical device to ensure conformity against UK legislation by offering a range of flexible certification services providing you with efficient pathways to bring your product to market.

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BSI is designated to issue article 16(4) certificates for all types of medical devices and IVDs that are subject to activities laid down in Article 16(2)

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Show medical device safety with IEC 60601 testing and use your report for UKCA, CE certification and access to 50+ markets via the IECEE CB Scheme.

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Clinical evaluation is an ongoing process that starts during device development and continues throughout its lifecycle. It ensures your device’s safety and performance are supported by sufficient clinical evidence for certification and beyond.

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