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 and UK Approved Body?

The role of a Notified Body and of a UK Approved Body is to conduct a Conformity Assessment under the relevant EU Regulations (MDR and IVDR) or UK legislation (UK MDR 2002), 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 full-scope UK Approved Body assessing Medical Devices and IVDs and it is the only one reviewing all three types of devices covered by UK MDR 2002:

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

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

Guide to Conformity

To navigate the complex MedTech regulatory landscape often comes with challenges.

This video helps you navigate the conformity journey to place your product on the market. It also provides an overview of medical devices and IVDs regulatory framework, as well as BSI Regulatory Services offer for Quality Management System (QMS) and product certification (CE and UKCA).

Discover what you need to know about Notified Body and UK Approved Body certification services and MedTech 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 the manufacturers, its authorised representative, a supplier, or a commercial competitor regarding design, development, marketing or maintenance of medical devices and IVDs, or processes under assessment. We provide whitepapers, training courses and additional resources to support you every step of the way.