The labeling of medical devices comprises all information affixed to the product itself, its packaging, or its label to identify the product and enable its safe use. The legal standard is Annex I Chapter III of Regulation (EU) 2017/745, which sets out general requirements for medium, format, content, legibility, and location in Section 23.1, and specifies detailed mandatory label content in Section 23.2. Labeling is thus part of the general safety and performance requirements and not merely a matter of product design. The editorial and terminological design of product information as a whole is described in the entry Labeling.
General Requirements
According to Section 23.1, the medium, format, content, legibility, and location of the information must be appropriate to the product, its intended purpose, and the technical knowledge of the intended users. The information must be affixed to the product itself; if this is not possible, it may appear on the packaging of the individual unit or on the packaging of multiple products. The labeling must be in human-readable form and may be supplemented by machine-readable information such as radio frequency identification or barcodes.
Residual risks must be communicated as limitations, contraindications, precautions, or warnings. Labeling thus assumes a function in risk management: it is the final level of risk control after design and protective measures have been exhausted.
Mandatory Information on the Label
Section 23.2 requires, among other things, the name or trade name of the product, information for the identification of the product, package contents, and intended purpose, the name and address of the registered place of business of the manufacturer and, for manufacturers outside the Union, additional information on the authorized representative, the batch number or serial number preceded by the designation or an equivalent symbol, the carrier of the unique device identifier, and the expiry date or, if such a date is absent, the date of manufacture.
In addition, information on special storage or handling conditions, for products supplied sterile an indication of the sterile state and the sterilization method, warnings and precautions requiring immediate attention, the Union-wide uniform indication for single-use products, for reprocessed single-use products the number of reprocessing cycles already completed, the indication custom-made device, and the indication that it is a medical device or, for investigational devices, the indication exclusively for clinical investigation.
Unique Device Identifier and Machine-Readable Information
The carrier of the unique device identifier must be affixed to the label and to all higher levels of packaging in accordance with Article 27(4) and Annex VII Part C; shipping containers are excluded. The basic UDI, by contrast, is not a label component but the primary key for entries in the product database and appears in certificates and in the EU declaration of conformity.
Languages and Symbols
The Regulation leaves it to the Member States to determine in which languages the information required by Annex I Section 23 must be provided; for the German market, information in German is required. Translations of this information are not considered conformity-relevant changes under Article 16(2), but they trigger separate obligations for the translator.
Where appropriate, internationally recognized symbols corresponding to harmonized standards or common specifications must be used; in the absence of such standards, the symbols must be explained in the accompanying documentation. Which symbols are available for this purpose is presented in the entry Symbols on Medical Devices.
Distinction from Medicinal Product Labeling and CE Marking
For medicinal products, labeling follows the marketing authorization dossier and is approved by the authorities; any change requires a variation. For medical devices, the manufacturer is responsible for labeling as part of the conformity assessment, and the Notified Body reviews it as part of the technical documentation but does not approve it as a standalone document. In terms of content, the mandatory information differs significantly, as for devices the focus is on intended purpose, user group, reprocessing, and traceability rather than active substance and dosage.
The labeling within the meaning of Annex I must be distinguished from the CE marking under Article 20, which expresses the conformity of the product and must be affixed in a visible, legible, and indelible manner in accordance with the rules set out therein. It supplements product labeling but does not replace any of its mandatory information.
Relevance for clinical trials
Investigational devices do not bear CE marking but must be labeled as exclusively for clinical investigation in accordance with Annex I Section 23.2; in addition, the requirements for documentation of the clinical investigation under Annex XV apply. The labeling must also indicate batch or serial number, storage conditions, and assignment to the investigation in such a way that product issue, return, and destruction can be documented in a traceable manner.
For multilingual and multinational investigations, it must additionally be verified which language versions must be available at which investigational site and how changes are versioned and exchanged. Full-service CROs such as Mediconomics support sponsors and manufacturers in reviewing labeling drafts for investigational devices against the requirements of the Regulation and the countries involved, and in preparing the transition from investigational labeling to market labeling.
Frequently Asked Questions (FAQ)
Must every piece of information appear on the product itself?
No. Section 23.1 requires the information on the product itself only where this is practicable and appropriate; otherwise, the packaging of the individual unit or the packaging of multiple products is sufficient.
Which language is required?
This is determined by the Member State in which the product is made available. For multiple markets, multiple language versions or multilingual labeling are required accordingly.
May symbols completely replace text?
Symbols are permitted and encouraged if they comply with harmonized standards. For lay users and for non-standardized symbols, an explanation in the accompanying documentation is required.
Regulatory References
- Regulation (EU) 2017/745, Annex I Chapter III Section 23.1 — general requirements for product information
- Regulation (EU) 2017/745, Annex I Chapter III Section 23.2 — mandatory information on the label
- Regulation (EU) 2017/745, Article 27(4) and Annex VII Part C — affixing the carrier of the unique device identifier
- Regulation (EU) 2017/745, Article 20 — CE marking of conformity
- Regulation (EU) 2017/745, Article 16(2) — translation of information required by Annex I Section 23
