Medical device labelling under MDR is defined by section 23 of Annex I. It is an exhaustive list of items of information, each subject to conditions of application depending on the type and class of the device. An incomplete label constitutes a non-conformity with the GSPR — and it is one of the first points checked during market surveillance inspections.
Mandatory information on the label
Section 23.2 lists the information that must appear on the label according to the characteristics of the device.
Name or trade name and registered address of the manufacturer. For non-EU manufacturers: also the name and registered address of the EC REP authorised representative.
Information allowing the device and its contents to be identified: the name of the device or the product, the reference, the batch number (preceded by “LOT” or the corresponding symbol) or serial number, the quantity in the packaging.
The word “STERILE” for sterile devices, together with an indication of the sterilisation method used where relevant.
Expiry date in an unambiguous format — the YYYY-MM or YYYY-MM-DD format is recommended. A format such as “12/27” is ambiguous and non-compliant.
Particular storage and/or handling conditions, where applicable.
Any warnings or precautions to be brought to the attention of the user or any other person.
CE marking, together with the notified body identification number where applicable.
UDI code in accordance with Article 27.
ISO 15223 symbols
ISO 15223-1:2021 defines the symbols used on medical device labels. Their use makes it possible to present the information in a compact and universally understandable manner, without the need for translation.
The most common symbols: the “manufacturer” symbol (a stylised house with an arrow), the “authorised representative in the European Community” symbol (the letters EC inside a box), the “use by” symbol (an hourglass), the “do not re-use” symbol (a crossed-out figure 2), the “sterile” symbol (the letters STERILE in a box), the “batch number” symbol (LOT), the “serial number” symbol (SN).
Manufacturers who were using symbols from earlier versions of ISO 15223 must verify their compliance with the 2021 version. Some symbols have changed between versions.
Language requirements
The manufacturer must ensure that the information appearing on the label is drawn up in the official language of the Member State where the device is placed on the market. For a device marketed in France, the textual information must be in French.
Universally recognised ISO symbols do not require translation. Textual information — contraindications, precautions, storage instructions — must be translated.
For devices marketed in several Member States, the label must cover all the languages concerned, or different labels must be used for each market.
Regulatory source: Section 23 of Annex I of Regulation (EU) 2017/745 — EUR-Lex