Conformity assessment & CE marking

From the choice of the conformity assessment procedure to CE marking

Manufacturers in Europe must pass a conformity assessment procedure for the approval/marking of their product. Depending on the medical device class (1-3), different conformity assessment procedures (quality management system QMS) and a technical documentation assessment (Annex IX of the Medical Device Regulation EU-MDR , a type examination (Annex X of the MDR), and a product conformity assessment (Annex XI) are applied. The conformity assessment procedure is the authorization to place the product on the market with CE marking. The conformity assessment, e.g., the type examination, is carried out by Notified Bodies / testing institutes such as Technical Inspection Association (TÜV).

The conformity assessment procedures require a certified QMS. The establishment and maintenance of QMSs were originally based on the EN ISO 9001 standard followed by EN ISO 13485: 2016 . With the new European MDR, a QMS is an important tool for all medical device manufacturers to remain competitive. For medical devices of all classes, manufacturers must submit the technical documentation of the medical device to a Notified Body.

Once you have submitted and created the Declaration of Conformity, the CE mark can be applied to your product and you can register your medical device. In Germany, the German Institute for Medical Documentation and Information (DIMDI) is responsible fo medical device registration. You next issue the market release and place the product with the CE mark on the market. After the product launch, you are obligated to continually monitor feedbacks and incidents from the market (risk management).

Legislation differs in other countries. Medical device manufacturers in the US, for example, must apply for approval from the Food and Drug Administration (FDA) when placing the product on the US market . The most important approval procedure here is premarket notification in accordance with 510(k) (FDA). Other submission pathways are Pre Market Approval Applications (PMA) with class III medical devices or DeNovo submissions.

We can help you with everything from file submission and choice of conformity procedure to obtaining CE marking and the FDA approval of your medical device.

Feel free to contact us!