Organisme Notifié pour les Dispositifs Médicaux

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.

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.