CE Marking

The CE marking is a manufacturer's declaration that a product meets the applicable European Union health, safety and environmental requirements, allowing it to be placed on the market anywhere in the European Economic Area. For medical devices the relevant legislation is the Medical Device Regulation (EU) 2017/745, or the In Vitro Diagnostic Regulation (EU) 2017/746 for diagnostics.

It is worth being precise about what the marking does and does not signify. It is a statement of regulatory conformity, not a quality award, not a mark of clinical superiority and not a guarantee of reimbursement. A device can be lawfully CE marked and still fail to be adopted, because purchasing and health technology assessment decisions are made separately.

Conformity assessment routes

The route depends on the risk class of the device. Class I devices that are not sterile, do not have a measuring function and are not reusable surgical instruments may be self-certified by the manufacturer. All higher classes require a Notified Body to assess the quality management system and the technical documentation before a certificate is issued and the marking applied.

What sits behind the marking

• Technical documentation covering design, manufacture and performance.
• A quality management system, in practice almost always aligned to ISO 13485.
• Risk management in line with ISO 14971.
• Clinical evaluation demonstrating safety and clinical benefit.
• A post-market surveillance plan and, for higher risk devices, post-market clinical follow-up.
• An EU Declaration of Conformity signed by the manufacturer.

After the marking is applied

CE marking is not a one-off event. Certificates have expiry dates and require surveillance audits, technical documentation must be kept current, and significant design changes must be notified to the Notified Body. Field safety issues, vigilance reports and periodic safety update reports all feed back into whether the certificate remains valid.