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 (ISO 13485)
- Batch verification/release
For non-medical device CE marking services, please visit our global website.