Compared to the MDD 93/42/EEC, the new Medical Devices Regulation EU 2017/745 (MDR) sets out additional requirements manufacturers need to adhere to for device labeling. According to Art. 2 of the MDR, a label is “the written, printed or graphic information appearing either on the device itself or on the packaging of each unit or on the packaging of multiple devices”.
Chapter III of Annex I clarifies that the information accompanying the device (label and instructions for use) is meant to identify the medical device and its manufacturer, as well as to provide essential information on safety, use, and performance.
Manufacturers are required to provide human-readable labels, which can eventually be supplemented by machine-readable information, such as bar codes. Commission Regulation (EU) No 207/2012 specifies the devices whose instructions for use can be currently supplied in electronic format.
Among the label requirements listed in Chapter III, Section 23 of Annex I, a label should bear:
- The name or trade name of the device;
- The Authorized Representative’s name and contact details (for non-EU manufacturers);
- The necessary information to allow users to identify the device, its intended purpose (if not obvious), and the content of the packaging;
- The UDI carrier (alternatively it can be on the packaging);
- The date of manufacture (when no expiration date can be indicated), which can be part of the lot/serial number, provided that it is clearly identifiable;
- Warnings or Precautions which need to be brought to the immediate attention of the users;
- Indication of single-use, if the device is not reusable;
- An indication that the device is a medical device. If the device is intended for clinical investigation only, then the label must contain the words “exclusively for clinical investigation”;
- An unambiguous indication of the time limit for safely using or implanting the device (year and month at least), where this is relevant;
- Where applicable, an indication that the device contains or incorporates:
- A medicinal substance, including a human blood or plasma derivative; or
- Tissues or cells, or their derivatives, of human origin; or
- Tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012.
Art. 10 of the MDR specifies that manufacturers should ensure that the device is accompanied by the information set out in Section 23 of Annex I, and that such information is provided in an official language(s) determined by the Member State where the device will be marketed. We present specific national requirements as part of the MDlaw blog series available on MDlaw News. Distributors are now responsible to verify that such information is in the appropriate language mandated by the local authorities (MDR Art. 14.2.b).
The MDR also specifies the mandatory information which must be affixed on the packaging maintaining the sterile condition of the device (MDR Annex 1.23.3).
Furthermore, the label should be appropriate to the particular device, its intended purpose, and the target users. Additionally, as per Art. 7 of the MDR, it shall be prohibited to use text, names, trademarks, pictures, and figurative or other signs that may mislead the user or the patient in the labeling, instructions for use, making available, putting into service and advertising of devices.
Additionally, manufacturers of implantable medical devices shall generate an implant card and patient manual, as per Article 18 of the MDR.
The increased labeling requirements introduced by the MDR also reflect in the new ISO 15223-1:2021, which specifies the symbols to be used by manufacturers on the medical device itself, on its packaging, or in the accompanying information. Among the new symbols:
- The symbol indicating if the device is a Medical Device (MD);
- The symbol identifying the repackaging of a device;
- The UDI symbol;
- The name of the patient (for particular medical devices).
It is important to note that manufacturers shall also upload to their website (if they have one) their device’s instructions for use in the official language determined by Member State where the device is made available (MDR Annex 1. 23.1).
Timeline
Labeling obligations apply to MDR compliant devices as of May 26, 2021, apart from affixing the UDI carrier for which additional time was granted (see below). However, the assignment of the Basic UDI-DI applies from May 26, 2021.
Title: Timeline to affix UDI carrier
Source of the image: European Commission (2020)
Furthermore, importers must indicate their name, registered name or registered trademark, their registered place of business, and the address at which they can be contacted on the device, or its packaging, or in a document accompanying the device. This obligation applies from May 26, 2021, and concerns MDR-compliant devices and legacy devices.
Are you a manufacturer of medical devices? We will gladly assist you in reaching compliance for the EU market! Contact us today!
In case you are an importer or a distributor, be aware of new obligations set out by Articles 13 and 14 of the MDR. Especially, when translating the labeling, do not forget Article 16(4) and the related MDCG Guidance 2021-23 on the need for a certified QMS!
Sources:
- EUR-Lex (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retried on 21/09/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
- Certifico (2021). ISO 15223-1:2021 – New symbols for medical devices. Retrieved on 21/09/2021 from https://certifico.com/newsletter/archive/view/listid-69-costruzioni/mailid-68147-iso-15223-1-2021-new-symbols-for-medical-devices#:~:text=This%20document%20specifies%20symbols%20used,to%20meet%20different%20regulatory%20requirements.
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