What does the CE mark on a medical device mean?
In this context, labeling includes the CE mark, which is a symbol of compliance with European Union requirements. Introducing the CE mark on the packaging signifies that the product has undergone necessary assessments and meets all EU requirements for medical devices concerning safety, effectiveness, and quality. Additionally, information provided on the label, such as the catalog number, expiration dates, or usage instructions, plays a significant role in the proper use, post-market surveillance and vigilance of the device.
What are the current regulations related to the labeling of medical devices?
With the entry into force of the Regulation 2017/745, new labeling requirements for medical devices have been implemented, and described in detail in Annex I to the MDR, specifying the general safety and performance requirements.
In July this year, an update of the EN ISO 15223-1 standard was published concerning the symbols and information provided on the labels of medical devices. The intent of the revision of the Standard was to bring clarity to the definitions and descriptions of the symbols used so far and adding new ones adapted to the new legal requirements strictly related to the entry into force of Regulation 2017/745 (MDR).
The EN ISO 15223-1 standard is not yet harmonised with Regulation 2017/745, but manufacturers can start to comply with the new regulations immediately.
What is new in the EN ISO 15223-1: 2021 standard?
The EN ISO 15223-1: 2021 standard introduces the indication “MD”, i.e. graphic information that a given product is a medical device. New symbols were also introduced to identify the economic operators – the distributor and the importer. The UDI code symbol, or the symbol informing that the product has been repackaged are as well functional. Additionally, there are new symbols indicates the sterile barrier system.
Furthermore, new graphics were added informing that the product contains:
– as an integral part, a substance that, when used alone, could be considered a medicinal product;
- biological material of human origin,
- biological material of animal origin,
- harmful substances (carcinogenic, mutagenic or reprotoxic or endocrine disrupting substances),
- human blood or plasma derivatives.
A significant change introduced by the new regulation is the obligatory use of harmonized symbols.
What’s new in Regulation 2017/745 (MDR)?
The MDR regulation in terms of labeling introduces two important issues:
- a mandatory information that a given product is a medical device, or obligatory use of harmonized symbols
- placing the UDI code carrier on the device label.
Placing the UDI code on the labels is not obligatory as of the date of entry into force of the MDR Regulation for most classes of medical devices. The document provides for a transition period for class I devices – until May 26, 2025, classes IIa and IIb – until May 26, 2023. Producers of class III devices are required to place the UDI code on the product labeling from May 26, 2021.
What essential information should be provided as part of the labeling of the medical device?
In order to correctly label the medical device, the manufacturer should provide the fallowing information on the packaging / label of the device:
- name or trade name of the product,
- an indication that the device is a medical device [or a harmonized symbol]
- CE mark with the number of the notified body (if applicable),
- manufacturer’s name and address,
- information necessary to identify the product, the contents of the packaging,
- if it is not obvious for the user, the intended use of the device as intended by the manufacturer should be indicated;
- the lot number or serial number of the product preceded by the words LOT NUMBER or SERIAL NUMBER, or an equivalent harmonized symbol, as the case may be;
- the UDI carrier;
- if the date until which the safe use of the product is not given – the production date. Such date of manufacture may be included as part of the batch number or serial number provided that the date so stated is clearly identifiable;
- information on any special storage or handling conditions that apply;
- if the device is intended for single use – information about this [or a harmonized symbol]
- warnings or information on necessary precautions, which should be immediately brought to the attention of the product user or another person,
- in the case of articles consisting of substances or mixtures of substances which are intended to be introduced into the human body via a body orifice or applied to the skin, and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituents or constituents responsible for achieving the principal intended action;
For sterile products:
- an indication permitting the sterile packaging to be recognized as such;
- a declaration that the device is in a sterile condition;
- sterilization method;
- product description;
- the month and year of manufacture;
- an information to check in the instructions for use what to do if the sterile packaging is damaged or opened before use.
If the devices is intended for clinical investigations:
- if the device is intended for clinical investigation only, the words “exclusively for clinical investigations”.
If the device is a custom-made:
- the words “custom-made device“.
What are the consequences of incorrect labeling of a medical device?
The labeling of a medical device is essential for its manufacturer. Misleading product labelling may cause a very serious consequences, such as safety risk or financial penalties. Sanctions for non-compliance with the requirements of the regulation are set at the level of the Member States.
In the Polish act on medical devices, administrative fines for misleading the user or patient as to the intended use, safety and performance of the device are determined up to the amount of PLN 5,000,000. Correct labeling will avoid high financial penalties in this respect. In addition, it will contribute to reducing the risk of using the product in a different way than it’s intended purpose.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,
- ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements