What is CE marking?

CE marking is the formal confirmation that a medical device or IVD complies with all applicable European Union regulatory requirements. It indicates that the manufacturer has performed the conformity assessment in accordance with the appropriate route under the MDR or IVDR. The CE mark allows the product to be legally placed on the EU market and distributed within EU member states.

The legal framework for CE marking is set out in the Medical Device Regulation (MDR) 2017/745 for medical devices and in the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 for IVDs. Both regulations define the obligations related to product identification, UDI system implementation, labeling and instructions for use. Technical details are described in Annex I to MDR/IVDR and in standard EN ISO 15223-1.

When is CE marking not required?

CE marking is not required for:

  • devices used exclusively for research purposes (RUO),
  • in-house laboratory-developed tests (LDTs) under Article 5(5) of MDR/IVDR,
  • products that are not considered medical devices or IVDs under EU law.

Mandatory label elements under MDR/IVDR

Each CE-marked product must carry a clear and durable label containing the following information:

  • trade name or product identifier,
  • product type: “MD” or “IVD”,
  • CE mark and Notified Body number (if applicable),
  • name and address of the manufacturer,
  • UDI carrier,
  • production date and/or expiry date,
  • lot number or serial number,
  • storage and transport conditions (if applicable),
  • information about single use (if applicable),
  • warnings and precautions,
  • packaging content and identification of kit components (if applicable).

EN ISO 15223-1:2021 and label symbols

EN ISO 15223-1:2021 standardizes graphic symbols that may be used in place of text descriptions, provided they are understandable to the end user. Key labeling requirements include:

  • mandatory “MD” or “IVD” symbols to identify product type,
  • symbols for importer and distributor,
  • UDI symbol for product traceability,
  • symbol for repackaging by a third party,
  • symbols for biological materials, sterility, and hazardous substances.

Labeling of sterile, custom-made, and investigational products

Additional requirements apply to specific product types:

  • Sterile devices: labeling must include method of sterilization, sterility status, instructions for handling damaged packaging, and expiry date,
  • Custom-made devices: must be labeled “custom-made device”,
  • Investigational devices: must be marked “for clinical investigation only”,
  • IVDs for performance evaluation: must be marked “for performance study use only”.

Stages of the CE Marking Process

1. Determining the product classification: Based on the classification rules set out in Annex VIII of the MDR or IVDR, the manufacturer determines the risk class of the device (I, IIa, IIb, III or A, B, C, D for IVDs). The class defines the subsequent conformity assessment pathway.

2. Selecting the appropriate conformity assessment procedure: Depending on the risk class and type of device, the manufacturer selects the conformity assessment route – this may involve an audit by a notified body or an internal assessment only.

3. Preparing the technical documentation: The manufacturer compiles comprehensive technical documentation in accordance with Annex II of the MDR or IVDR, including the device description, test results, risk analysis, instructions for use, and labeling.

4. Implementing a quality management system (QMS): For higher-class devices, it is necessary to implement a QMS compliant with ISO 13485, which will be assessed by a notified body.

5. Assessment by a notified body: For devices above Class I, the manufacturer must submit the technical documentation and QMS for assessment by a notified body. A positive assessment results in the issuance of a certificate of conformity.

6. Drafting the EU declaration of conformity: Following successful conformity assessment, the manufacturer draws up and signs the EU declaration of conformity, confirming compliance with all applicable requirements of the regulation.

7. Affixing the CE marking: The manufacturer affixes the CE marking to the device, its packaging, and documentation in accordance with MDR/IVDR requirements. Additionally, if a notified body is involved, its identification number must be placed next to the CE marking.

What Documents Are Required to Obtain CE Marking?

To obtain CE marking for a medical device or IVD, the manufacturer must prepare a complete set of documents demonstrating compliance with the requirements of the MDR or IVDR. The core documents include:

  • Technical documentation – includes a detailed description of the device, its intended purpose, design, test results, and risk analysis (in accordance with Annex II of the MDR/IVDR).
  • EU declaration of conformity – the manufacturer’s official statement that the device meets all applicable requirements.
  • Instructions for use – developed in accordance with the requirements of Annex I, containing information necessary for the safe use of the device.
  • Device labeling – includes mandatory markings, symbols, and manufacturer data as per ISO 15223-1.
  • Clinical evidence – clinical investigation reports or performance evaluation (for IVDs) demonstrating the device’s safety and effectiveness.
  • Notified body certificate – if the device requires the involvement of a notified body, its certificate must be included in the documentation.

Depending on the device classification and conformity assessment procedure, the scope of required documentation may be extended.

Common errors and risks in CE marking

Frequent issues found during audits or inspections include:

  • missing or incorrect UDI format and placement,
  • use of outdated or incorrect symbols not compliant with EN ISO 15223-1:2021,
  • incomplete or illegible labeling information,
  • mismatch between label content and Declaration of Conformity,
  • inaccurate identification of the manufacturer or economic operators.

Consequences of incorrect CE marking

Improper CE labeling can result in:

  • prohibition of product placement on the EU market,
  • suspension or withdrawal of the conformity certificate,
  • administrative fines (e.g., up to €1 million in some member states),
  • mandatory recall or withdrawal from the market,
  • impaired traceability and post-market surveillance effectiveness.

CE vs. other product markings

CE marking is a legal requirement in the EU and should not be confused with voluntary or region-specific markings such as:

  • GS mark (product safety in Germany),
  • UKCA mark (UK market equivalent),
  • CB/IEC certificates (technical compliance, not legal placement on EU market).

Only CE marking provides proof of compliance with essential EU regulatory requirements for medical devices and IVDs.

How Pure Clinical can help with CE marking

Pure Clinical provides expert support in CE marking implementation, including:

  • label and IFU compliance verification,
  • design of complete label sets and instructions compliant with MDR/IVDR and harmonised standards,
  • assistance with UDI implementation and EUDAMED data preparation,
  • label audits in line with Notified Body expectations.

We work with high-risk products, custom-made devices, and investigational use kits to ensure full compliance with the latest EU and MDCG requirements.

Regulatory and normative references

  • Regulation (EU) 2017/745 (MDR)
  • Regulation (EU) 2017/746 (IVDR)
  • EN ISO 15223-1:2021 – Medical device labeling symbols

FAQ

Is the CE mark required for all IVD and MD products?

No. CE marking is required only for products that fall within the scope of the MDR or IVDR. Certain devices are exempt, such as RUO (Research Use Only) tests, in-house developed tests (LDTs) used under Article 5(5), and products not intended for clinical or diagnostic use.

Can the CE mark be placed only on the outer packaging?

Not by default. The CE mark must be affixed visibly, legibly, and indelibly to the device or its packaging. It can appear only on the outer packaging or in the instructions for use if justified due to the device’s size or nature.

How can you verify whether a CE mark on a device is valid?

To verify CE mark validity, compare the label with the Declaration of Conformity, check the Notified Body number (if applicable), and confirm product registration in EUDAMED. The CE mark must match the device class and legal manufacturer listed in official documentation.

What should be done in case of incorrect CE marking?

If CE labeling is incorrect, the product must not be placed on the market. Manufacturers should issue a field safety corrective action, notify competent authorities, and revise both labeling and technical documentation before re-distribution.

Is CE marking recognized outside the European Union?

Generally not. Countries like the UK, USA, Canada, and others have their own regulatory systems. For example, the UK requires UKCA marking, and the US requires FDA clearance. CE marking alone is not sufficient for non-EU markets.