Is CE marking a certification?

No. CE marking is a legal conformity marking indicating that the manufacturer declares the product meets applicable EU legislation. It is not a quality seal or an EU 'approval'.

When is a Notified Body required for medical devices?

For Class IIa, IIb and III devices, and for certain Class I categories (Is, Im, Ir). The CE symbol must then be followed by the Notified Body’s 4-digit identification number.

Where and how should the CE symbol be affixed?

Affix it visibly, legibly and indelibly on the device. If not possible, place it on the packaging and in the IFU. Use the official proportions; the height is generally at least 5 mm (waived for small devices).

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CE marking (CE mark) — medical devices

CE marking is the manufacturer’s formal declaration that a product conforms to all applicable EU legislation (safety, health and environmental protection) and can circulate freely within the EEA. For medical devices, CE marking signifies conformity with the EU Medical Device Regulation (EU) 2017/745 (MDR) or, for IVDs, the IVDR (EU) 2017/746. It is not a quality seal or third-party “approval”; it is a legal conformity marking placed by the manufacturer.

Legal conformity marking
Manufacturer’s declaration
Mandatory in the EEA

What CE marking is (and is not)

Is: A legal indication that the device meets EU requirements and may be placed on the EEA market.
Is not: A performance “quality mark”, country-of-origin label, or an EU/Commission product endorsement.
Who is responsible: The legal manufacturer (or Authorized Representative signing the DoC, where allowed) affixes the mark and assumes full responsibility for compliance.

When a Notified Body is required

Class I (non-sterile, non-measuring, non-reusable surgical instrument): typically self-declaration by the manufacturer.
Class Is / Im / Ir, IIa, IIb, III: Notified Body (NB) assessment is required to the extent defined by the MDR conformity assessment route (e.g., Annex IX, X/XI). The CE symbol is then followed by the NB’s 4-digit identification number.

Medical device CE marking — process overview

1) Determine device & risk class

Classify under MDR Annex VIII rules; classification drives the conformity assessment route and NB involvement.

2) Establish a compliant QMS

Implement and maintain a QMS that meets MDR Article 10(9); ISO 13485 alignment is the market norm and typically audited when an NB is involved.

3) Compile technical documentation (Annex II & III)

Technical file covering device description, design/manufacture, risk management, verification/validation (incl. software where applicable), GSPR evidence, and PMS/PMCF planning.

4) Clinical evaluation (Annex XIV)

Plan and document clinical evaluation per Article 61/Annex XIV using clinical data (own, literature, or equivalence where justified); define PMCF if needed.

5) Conformity assessment

Select and complete the MDR route appropriate for the class (e.g., Annex IX full QMS with tech documentation review; or Annex X/XI combinations). Undergo NB review where required and obtain certificates.

6) EU Declaration of Conformity

Draw up and sign the DoC referencing applicable legislation/standards and maintain it with the technical documentation.

7) Affix CE marking

Affix the CE symbol (and NB number when applicable) visibly, legibly, indelibly on the device; if not possible, on packaging and IFU. Respect the official proportions; minimum height is generally 5 mm (waived for small-scale devices).

8) Post-market obligations

Monitor performance (PMS), trend and investigate complaints/vigilance, execute PMCF where planned, and maintain technical documentation and certificates over the device lifecycle.

Marking rules — quick checklist

Placement: On the device; if not possible or not warranted, on packaging and IFU.
Format: Use the official “CE” proportions; vertical dimension generally ≥ 5 mm; keep it visible, legible, indelible.
NB number: Add the 4-digit Notified Body number immediately after “CE” when an NB participated in conformity assessment.
Timing: Affix before placing on the market and maintain compliance thereafter.