The CE mark is a regulatory conformity marking indicating that a medical device meets European Union requirements regarding safety, performance, and health protection. For medical devices, CE marking is mandatory for placing products on the market in the European Economic Area (EEA), which includes EU Member States as well as Iceland, Liechtenstein, and Norway. Although it is not legally required outside Europe, manufacturers often use it for other regions because it demonstrates compliance with one of the strictest regulatory systems in the world.

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Regulatory framework: MDR and IVDR

CE marking of medical devices is based on two key European regulations:

MDR (Medical Device Regulation – EU 2017/745)
Covers most medical devices, from simple consumables to implants and complex equipment.

IVDR (In Vitro Diagnostic Regulation – EU 2017/746)
Applies to diagnostic products, including tests, reagents, and laboratory equipment.

These regulations replaced earlier Directives and introduced stricter requirements for clinical evidence, post-market surveillance, traceability, and oversight of Notified Bodies.

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Classification and self-declaration

Medical devices are classified according to risk level:

MDR classes: I, IIa, IIb, III
IVDR classes: A, B, C, D

Lower-risk products may be subject to manufacturer self-declaration (without involvement of a Notified Body), provided all regulatory requirements are met.
However, for most devices — especially those of medium and high risk — conformity assessment by a Notified Body is required before the CE mark can be affixed.

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Difference between ISO 13485 and CE marking

It is important to distinguish between ISO 13485 and CE marking:

ISO 13485
An international standard for quality management systems in medical device manufacturing. Certification confirms that the organization has an established and controlled quality system.

CE marking
A legal requirement for access to the EU market, confirming that a specific product complies with MDR or IVDR.

In other words, ISO 13485 certification demonstrates that the manufacturer operates a robust quality management system, while CE marking confirms that the product itself is regulatorily compliant and may be legally sold in Europe.