Labels and instructions for use (IFUs) of medical devices must comply with Medical Devices Regulation and IVD Medical Devices Regulation. Based on intended use, mode of operation, and other characteristics, medical devices must include certain icons and symbols either on the labels or in the IFUs, or both. It is important to note that information on medical devices must be in a format correctly understood by every stakeholder in the supply chain of the device.
How are standards developed?
Recognised European Standardization Organisations (CEN, CENELEC) develop a wide range of standards to support a functioning single market. It starts with a standardisation request from the European Commission to CEN and CENELEC. The process is based on a public-private-partnership between the Commission and the standardisation entities, whose roles and responsibilities are ruled by the 2012 Standardisation Regulation. If the standardization bodies accept the request, they draft new standards, which are then evaluated by technical experts supporting the European Commission. Once the standardisation work is completed, CEN and CENELEC propose to the Commission the publication of new standards in the Official Journal of the European union. Once listed in the Official Journal, they can be considered harmonised standards that allow manufacturers to presume conformity with the legal requirements they cover.
In this framework, EN ISO 15223-1:2021 has recently been updated with the aim to improve definitions and descriptions through new symbols aiming at aligning various regulatory requirements.
Harmonised standards for medical devices’ labels
In January 2022, the Journal of the European Union published harmonised standards for medical and health care products, including symbols that manufacturers must provide for their products.
On 4 January 2022, EN ISO 15223-1:2021 has been added in the Annex to Implementing Decision (EU) 2021/1182 as fully in line with requirements as per Regulation (EU) 2017/745, Annex I, Chapter III, Article 23.1(h): ‘’Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS.[..]’’
This harmonised standard deals with the symbols that the manufacturer has to supply in order to deliver essential and comprehensive information on medical devices. Such symbols can be used on the medical device itself, on its packaging, or in the accompanying information.
In this context, manufacturers that follow the harmonised standard EN ISO 1223-1:2021 shall benefit from a presumption of conformity with the corresponding essential requirements set out in the MDR.
Are you a manufacturer planning on placing your product on the EU market? Do you wish to know more about compliant labels for medical devices?
Do not hesitate to contact Obelis, we will not only support you throughout the market pre-accession process, but we will also maintain you on track with the new standardisation activities your company might benefit from!
Sofia Belmare Ingrande
Regulatory Affairs Department
18/05/2022
References:
· European Commission..(2022). COMMISSION IMPLEMENTING DECISION (EU) 2022/6 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment . Retrieved on 18/05/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0006&from=EN
· MDCG. (2021). MDCG 2021-5 Guidance on standardisation for medical devices. Retrieved on 18/05/2022 from https://ec.europa.eu/health/system/files/2021-04/md_mdcg_2021_5_en_0.pdf–