Notified Body and UK Approved Body

Notified Body and UK Approved Body

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Notified Body Medical Devices
Notified Body Medical Devices
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What is the role of a Notified Body?

The role of a Notified Body and a UK Approved Body is to conduct a Conformity Assessment under the relevant EU Regulations (MDR and IVDR) and UK legislation, respectively.

The Conformity Assessment usually involves an audit of the manufacturer’s quality system (QMS) and, depending upon the device classification, a review of the relevant technical documentation provided by the manufacturer in support of the Safety and Performance Requirements (EU) or Essential Requirements (UK) for the device.

BSI Coverage

BSI The Netherlands (2797) is a leading Notified Body achieving full-scope designation under MDR and IVDR. We review your medical devices and IVDs to assess conformity against the applicable European legislations.

BSI UK (0086) is a UK Approved Body assessing Medical Devices and IVDs and the only one reviewing all three types of devices covered by UK Regulations:

  • General Medical Devices
  • Active Implantable Medical Devices
  • In-vitro Diagnostic Medical Devices

BSI dual designation facilitates the certification of your medical devices and IVDs, saving you from managing your product portfolio among different Notified Bodies and UK Approved Bodies.

Guide to Conformity

Welcome to your personal Guide to Conformity.

This video will guide you through the conformity journey to place your medical devices and IVDs onto the market. It also provides an overview of medical devices and IVDs regulatory framework, as well as, BSI services for your QMS and product certification.

Discover what you need to know about Notified Body and Approved Body certification and Medical Devices legislations!

 

What is outside the scope of a Notified Body and UK Approved Body

We carry out conformity assessments and verification activities with the highest degree of professional integrity and impartiality.

Definition of regulations and directives

We have no writing or decision-making rights on EU and UK legislation. Our input is considered during the debating stage. We assess against the requirements of the relevant legislation.

Consultancy

We are not allowed to provide consulting services to manufacturers, authorised representatives and suppliers regarding the design, construction, marketing or maintenance of medical devices under assessment. We provide guidance, training courses and additional resources to support you every step of the way.