What is a CE Mark?

A CE mark is required for all new products that are subject to one or more of the EU Directives or Regulations (e.g., EU MDR 2017/745 and EU IVDR 2017/746). Most new products that are marketed and sold in the European Economic Area (EEA) will require a CE mark.

*Source: ies.co.uk

To obtain CE certification for your medical device, perform the following steps:

1. Determine which set of EU Regulations apply to your medical device (i.e., MDR 2017/745 or IVDR 2017/746).
2. Classify your medical device according to the regulations. The classification of your medical device will determine the conformity assessment route that is needed.
3. Implement a quality management system (QMS) to manage the design and development of your medical device, as well as your quality processes.
4. Prepare the necessary documentation for your technical file, as outlined in the MDR or IVDR. This includes product description and specifications, manufacturing information, risk management plan, product verification and validation, clinical evaluation and post-market surveillance reports, and labeling.
5. Appoint an authorized representative to act on your behalf if your company resides outside of the EU.
6. Undergo an audit by a designated notified body. Once you pass your audit, obtain CE marking and ISO 13485 certificates from your notified body.
7. Prepare a Declaration of Conformity, which states that your device complies with the appropriate EU regulation.

*Source: emergobyul.com

Your CE mark should be affixed to the actual device or to its data plate. If this is not feasible, the CE mark should appear on the product packaging and accompanying documentation.

*Source: cemarking.net