The CE marking and technical documentation form the manufacturer's proof of conformity under the MDR. The technical documentation under Annex II demonstrates the requirements, the EU declaration of conformity confirms them, and the CE marking indicates them on the device.
Definition and legal basis
Under Article 2(43) of Regulation (EU) 2017/745 (MDR, the European Medical Device Regulation), the CE marking is a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements of the MDR and other Union harmonisation legislation. It is not a test mark of an authority but a declaration by the manufacturer, based on a conformity assessment that has been carried out.
Three building blocks belong together. The technical documentation demonstrates that the device meets the requirements (Article 10(4), Annexes II and III). The EU declaration of conformity records this formally (Article 19, Annex IV). The CE marking makes it visible on the device (Article 20, Annex V). The manufacturer draws up the declaration and affixes the marking only after it has demonstrated conformity by the applicable procedure (Article 10(6)). Depending on the risk class, a notified body is involved for this purpose.
The CE marking
Devices considered to be in conformity with the MDR must bear the CE marking. Custom-made devices and devices intended for clinical investigations are excluded (Article 20(1)). The rules in detail:
- The marking must be affixed visibly, legibly, and indelibly to the device or its sterile pack. Where that is not possible or not warranted, it is affixed to the packaging. It also appears in the instructions for use and on any sales packaging (Article 20(3)).
- It is affixed before the device is placed on the market. A pictogram or any other mark indicating a special risk or use may follow (Article 20(4)).
- Where a notified body was involved, its identification number follows the marking. It must also be indicated in any promotional material that mentions that a device fulfils the CE marking requirements (Article 20(5)).
- Annex V defines the form: the letters “CE” in prescribed proportions, with a minimum height of 5 mm, which can be waived for small devices.
EU declaration of conformity
The EU declaration of conformity states that the requirements of the MDR have been fulfilled for the device concerned. The manufacturer keeps it continuously up to date and translates it into the official languages of the member states in which the device is made available (Article 19(1)). By drawing up the declaration, the manufacturer assumes responsibility for compliance with the MDR and all other Union legislation applicable to the device (Article 19(3)). Where the device is subject to further legislation with its own declaration requirement, a single declaration is drawn up for all of it (Article 19(2)).
The minimum content is set out in Annex IV. It includes, among other things, information on the manufacturer, the Basic UDI-DI (see UDI), product name and intended purpose, the risk class, the statement of conformity with the MDR, where applicable the name and identification number of the notified body with the procedure and certificates, as well as place, date, and signature. For class I devices without a notified body, the declaration is the manufacturer's central proof of conformity (Article 52(7)).
Structure of the technical documentation
The manufacturer must draw up and keep up to date technical documentation for every device except custom-made devices. It must be such that conformity can be assessed (Article 10(4)). Annex II requires a clear, organized, readily searchable, and unambiguous presentation. The documentation must be kept available for at least ten years after the last device has been placed on the market, and for at least fifteen years for implantable devices (Article 10(8)).
| Structure under Annex II | Content (selection) |
|---|---|
| 1. Device description and specification | Description including intended purpose and intended users, Basic UDI-DI, patient group, principle of operation, risk class with justification, variants and accessories, previous and similar generations of the device |
| 2. Information to be supplied by the manufacturer | Complete set of labeling and instructions for use in the required languages |
| 3. Design and manufacturing information | Design stages, manufacturing processes and their validation, sites of design and manufacture |
| 4. General safety and performance requirements | Applicable requirements from Annex I, methods of demonstration, standards or other solutions applied, cross-references to the evidence documents |
| 5. Benefit-risk analysis and risk management | Benefit-risk analysis and results of risk management |
| 6. Product verification and validation | Preclinical and clinical data, reports and plans for the clinical evaluation and for post-market clinical follow-up, additional information in special cases |
Annex III supplements the technical documentation with regard to post-market surveillance, that is, the surveillance plan, report, and, where applicable, safety report (see post-market surveillance). The clinical evaluation is part of point 6.1 and is covered by the term Clinical Evaluation and PMCF. For devices with an integral medicinal product, additional information under point 6.2 is required (see Combination Product).
Usability in the technical documentation
Annex I, Chapter I, point 5 requires risks arising from use errors to be reduced. For this purpose, the manufacturer must take into account ergonomic features, the environment of use, and the technical knowledge, experience, education, training, and medical and physical conditions of the intended users, expressly including lay persons and persons with disabilities. For devices intended for use by lay persons, Annex I also contains a section of its own (point 22).
The evidence belongs in several places in the documentation:
- Point 1: The intended purpose and intended users form the starting point (intended use).
- Point 2: Labeling and instructions for use are part of the documentation (instructions for use).
- Point 4: This is where the methods and standards used to meet the requirement of Annex I point 5 are stated, including the justification, verification, and validation of the solutions.
- Point 5: Use-related risks feed into the benefit-risk analysis and risk management (risk management).
- Point 6.1: Among the tests, the MDR expressly names simulated-use testing. For software, it requires results of testing in a simulated or actual user environment prior to final release.
In practice, manufacturers bundle this evidence in the usability engineering file according to IEC 62366-1 and refer to it from point 4. This standard is not harmonized under the MDR (Implementing Decision (EU) 2021/1182 in the version of June 17, 2026, as of October 2026). Applying it is therefore regarded as an alternative solution within the meaning of point 4, which the manufacturer justifies. This is an inference from the legal text. The quality standards ISO 13485 and ISO 14971, by contrast, are listed in the decision.
Distinction from the US pathway
The CE marking applies to the market of the European Union. For the US market, the FDA decides in its own procedures, such as the 510(k) or the PMA. The two systems are independent of each other. A CE marking does not replace an FDA submission, and vice versa.
Under MDR Article 20, the CE marking shows that the manufacturer has demonstrated the conformity of its device. The basis is the technical documentation under Annexes II and III and the EU declaration of conformity under Article 19 and Annex IV. Where a notified body was involved, its identification number follows the marking.
The technical documentation is structured into device description, labeling and instructions for use, design and manufacturing information, demonstration of the general safety and performance requirements, benefit-risk analysis and risk management, and verification and validation.
Usability evidence belongs in several places. Annex I point 5 sets the requirement, and Annex II points 4 to 6.1 take up the evidence. The FDA procedures are independent of this.
Frequently asked questions (FAQ)
Is the CE marking a quality seal?
No. It is a declaration by the manufacturer that the device meets the applicable requirements. It is based on a conformity assessment in which, depending on the risk class, a notified body is involved. It is not awarded by an authority.
What must the technical documentation contain on usability?
The MDR does not name a usability section of its own. Relevant evidence is found in the documentation on the general requirements, in risk management, and in the verification and validation results, including simulated-use testing. It is common to bundle it in a usability engineering file with cross-references.
How long must the technical documentation be retained?
At least ten years after the last device covered by the declaration of conformity has been placed on the market. For implantable devices, it is at least fifteen years.
Is a CE marking sufficient for the US market?
No. The US requires a separate FDA procedure, for example 510(k) or PMA. The CE marking does not replace this procedure.
Does the declaration of conformity have to be translated?
Yes. It must be translated into the official languages of the member states in which the device is made available, and the manufacturer must keep it continuously up to date.
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More about our usability engineeringSources
- Regulation (EU) 2017/745 on medical devices (MDR)
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- ISO 14971:2019, Medical devices, Application of risk management to medical devices
- ISO 13485:2016, Medical devices, Quality management systems, Requirements for regulatory purposes
- Regulation (EU) 2017/745 (MDR), consolidated version of 01/01/2026
- Commission Implementing Decision (EU) 2021/1182 on harmonised standards for medical devices, consolidated version of 06/17/2026