The CE marking affixed to a medical device demonstrates compliance with the EU legislation in force. CE marking serves the purpose of marketing medical devices freely in the EU, provided that the devices comply with any national requirements in force.
Why do medical devices need to bear CE marking?
The CE marking affixed to a medical device demonstrates compliance with the EU legislation in force. CE marking serves the purpose of marketing medical devices freely in the EU, provided that the devices comply with any national requirements in force (e.g. registration and language requirements).
The medical devices regulation stipulates that medical devices must bear CE marking when marketed. In this context, marketing means the first time a medical device is made available for distribution or use (e.g. to a distributor, healthcare professional or patient). This applies regardless of whether the device is new or fully refurbished and irrespective of whether it is supplied free of charge or against payment.
However, the law does not require CE marking for custom-made devices, systems and procedure packs and devices intended for clinical investigation.
How to obtain CE marking
In order to obtain CE marking for a medical device, the device must fall within the definition of a medical device and be appropriately classified according to the classification of Annex VIII of the EU medical devices regulation. Medical devices are categorised into four risk classes: I (Im, Is) , IIa, IIb and III. Whereas class I represents the lowest risk, class III represents the highest. In the case of class I devices, the CE marking process is completed by the manufacturer. CE marking for high-risk classes must be completed by a notified body handling the certification.
The role of notified bodies
A notified body is an organisation authorised by the authorities to ensure that the medical device manufacturers have in place the required technical documentation and quality management system for processes and products associated with significant risk.
Manufacturers decide freely which notified body to use for their medical devices.
The technical documentation is prepared based on the general safety and performance requirements set out in Annex I of the medical devices regulation. The purpose is to document the product’s characteristics based on an assessment of the product’s quality, safety and performance.
In addition, the documentation must include a clinical evaluation. A clinical evaluation is an ongoing process in which clinical data, e.g. from scientific journals and own clinical investigations, are analysed and assessed to establish that the device complies with the general safety and performance requirements. The clinical investigation is to establish that the risks associated with the use of the device are acceptable when weighed against the expected benefits of the device.
The risk analysis is the main document of the technical documentation. It describes the risk aspects associated with the intended use of the device. The document is to enable an assessment of whether the risks associated with using the device are acceptable when weighed against the benefits that users or patients gain from using the device. The risk analysis must be continuously maintained and updated in response to changes affecting the product’s risk profile (e.g. changes in production and experience from users).
Declaration of conformity
On fulfilment of the safety and performance requirements and completion of the technical documentation, the manufacturer must date, sign and keep a declaration of conformity to certify that the product complies with the requirements of the executive order.
The manufacturer must keep the declaration of conformity and the technical documentation available for the Danish Medicines Agency for a period of at least 10 years after the manufacture of non-implantable and in vitro diagnostics medical devices has ceased, and for a period of at least 15 years in the case of implantable devices. The manufacturer is not required to submit the documentation to the Danish Medicines Agency, but must provide it on request.
When the manufacturer has signed the EU declaration of conformity, the CE marking can be affixed to the product. The CE marking itself must be visible, legible and indelible and must be affixed to the instructions for use to signify that the product meets the requirements of the law.
CE marking must also be affixed to the packaging and the product itself. In the case of sterile devices, the CE marking is affixed to the packaging that keeps the product sterile. In the case of devices involving a notified body, the CE marking must be accompanied by an identification number of the notified body having assisted in the assessment of the prodct.
The model for CE marking appears from Annex V of the medical devices regulation.