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.