What is a CE mark?
In the European Economic Area, commercial products must have the CE marking to ascertain that the product aligns with the health, safety, and environmental standards.
What is CE mark medical device?
The CE marking on medical devices indicates that the medical device meets all relevant European Medical Device Directives. It is a legal requirement for one to sell medical devices in the EU.
How do I get CE mark medical device?
Acquiring a CE mark by manufacturers is not a challenge. One requires some guidance to understand that it is a simple process. The following are the set procedures:-
The manufacturer must analyse the medical device to understand its function and possible uses. The EU directives and legislations dictate the implications of the medical device. Classifying the medical device is the responsibility of the manufacturer.
After accurate classification, the manufacturer identifies the relevant European Harmonised Standards. These include essential health and safety. They may also seek information on Notified Bodies that are necessary for CE mark medical device.
3. Technical Documentation
These include and are not limited to the following:-
- Medical device tests and assessments
- Product inspections
- Relevant audits
Once the manufacturer has completed and compiled this necessary technical documentation, they may issue a declaration of conformity.
4. Appointing a European Authorized Representative
Manufacturers outside the EU seeking CE mark medical devices have to appoint a European Authorised Representative.
If the medical device is a Class 1 product, a manufacturer can self-certify. Manufacturers ought to liaise with a notified body for upper-class products. The notified body conducts an audit of the technical documentation.
6. Attaching the CE marking
After certification, the manufacturer can affix the CE mark on the medical device and its relevant packaging. If the manufacturer is outside the EU, the European Authorised Representative is included alongside the CE mark.
7. National Provisions
The manufacturer has to comply with national requirements when introducing the medical device to several EU countries. They ought to register with the National Competent Authorities.
Some several resources and groups assist with making the CE mark medical device for manufacturers seamless. It is a simple process.