CE Marking Process for Medical Devices in the EU and Denmark

1. Purpose of CE Marking

CE marking documents that a medical device complies with applicable EU legislation, allowing free marketing within the EU provided national requirements (e.g., registration and language) are met. It is required when the device is first made available for distribution or use, whether new, refurbished, free, or paid. Custom-made devices, systems/procedure packs, and investigational devices are exempt from CE marking. Source: Danish Medicines Agency CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/ce-marking/

2. Achieving CE Marking

To obtain CE marking:

• Confirm the product meets the medical device definition.
• Classify correctly per Annex VIII rules (classes I-III for general devices; A-D for IVDs, with I/A lowest risk and III/D highest).
• Follow the appropriate conformity assessment procedure. For Class I/A devices, manufacturers self-certify. Higher classes require notified body certification. Source: Danish Medicines Agency CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/ce-marking/

3. Role of Notified Bodies

Notified bodies, designated by authorities, assess technical documentation and quality systems for higher-risk devices. Manufacturers may choose any notified body. Source: Danish Medicines Agency CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/ce-marking/

4. Technical Documentation and Clinical Evaluation

Documentation must address Annex I general safety and performance requirements, including ongoing clinical evaluation analysing data from sources like literature and own studies. The core is risk analysis, assessing acceptability of risks versus benefits, updated continuously. Source: Danish Medicines Agency CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/ce-marking/

5. Declaration of Conformity

After meeting requirements and preparing documentation, the manufacturer signs and retains a declaration of conformity. This, along with technical documentation, must be available to the Danish Medicines Agency for at least 10 years (non-implantable/IVDs) or 15 years (implantable) after last manufacture. Source: Danish Medicines Agency CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/ce-marking/

6. Affixing the CE Mark

The CE mark is affixed visibly, legibly, and indelibly to the device, packaging, and instructions for use (per Annex V model). For devices involving a notified body, include its identification number. For sterile devices, place on the sterility-maintaining package. Source: Danish Medicines Agency CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/ce-marking/

7. Legislation

• Regulation (EU) 2017/745 on medical devices (MDR)
• Regulation on in vitro diagnostic medical devices (IVDR)
• Danish executive order no. 957 of 29 April 2021 Source: Danish Medicines Agency CE Marking Page https://laegemiddelstyrelsen.dk/en/devices/ce-marking/