Before you can sell a medical device or IVD within Europe, you must place a CE Mark (CE Marking) on your product. The CE Mark is not a quality certification nor is it intended for consumers. It is used by the European Competent Authorities (National Ministries of Health) as a way to quickly determine whether your product has met all of the requirements of the Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC or the Active Implantable Medical Device Directive 90/385/EEC.
The Medical Device Directive states that companies must: -
- Compile a Technical File with evidence of compliance to the Medical Device Directive (or the IVD/AIMD Directives)
- Receive a CE Mark (CE Marking) certificate from a Notified Body if medium or high risk device
- Appoint an Authorized Representative if you have no physical location in Europe
- Register their medical devices with the Competent Authorities
Only after these requirements are satisfied are allowed to place the CE Mark on your device.