CE marking is a legal requirement for medical devices intended for sale in Europe.
There are three European CE marking Directives that specifically apply to medical devices manufacturers:
- The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive
- The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanently implanted in humans
- The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.
View the European Directives
BSI is designated as a Notified Body with a comprehensive scope under the MDD and the AIMD and can provide the full scope of services under the IVD Directive via a Notified Body partner. These services include:
- Technical documentation/file or design dossier assessment/review
- Device type examination
- Product quality assurance (based in ISO 13485)
- Production quality assurance (based in ISO 13485)
- Full quality assurance (ISO13485)
- Batch verification/release
A complete set of Notified Body CE marking Guidance Documents is available to download from the BSI website.
For further information BSI's schemes and services for medical devices in Europe, please Contact Us.
