Certification Process

CE certification for medical devices in class I is based on self-certification. The manufacturer must meet all the requirements of the CE regulations (see roadmap) and may apply the CE mark.

For all other products (Class Is, Im, IIa, IIb and III) the involvement and approval from a notified Body is required. The website of the European Union lists all Notified Bodies that are allowed to perform CE assessments for medical devices. Click here for an overview.

After going through the roadmap, the notified body must assess the product dossier for verification of compliance with all requirements of the medical devices directive. In addition, the quality system shall be assessed whether it meets the quality system requirements of the MDD. Assessing the product dossier by a notified body may take several months.

The evaluation by the notified body can result in a number of issues which need to be adjusted. Once all significant issues are solved there will issue a CE certificate. This is usually valid for a period of 3 years.

Continuous compliance with the medical device directive requirements and the organizations own quality management system is verified during yearly surveillance audits from the notified body. Every 3 years there shall be a renewal audit to get certified for another period of three years.