Updated guidance on standardisation for medical devices

In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on standardisation for medical devices, first published in 2021. In the medical device industry, the application of standards – whether harmonised standards or any another standard – is voluntary and the manufacturer choses to use them or not. At the same time, MDCG 2021-5 specifies that there are certain exceptions where standards can be regarded as mandatory. For instance, symbols and identification colours used on medical devices’ labels must conform to the harmonised standards. An additional clarification is needed for ‘’common specifications’’ published under MDR and IVDR, which are mandatory and cannot be used on a voluntary basis.

Harmonised standards in support of MDR and IVDR

In the field of medical devices and IVDs, CEN and CENELEC develop harmonised European standards through their specific Technical Committees (TCs). In support of this process, technical experts supporting the Commission services, “Harmonised Standards (HAS) consultants”, assess the drafted standards. Once the standardisation process is completed, CEN and CENELEC propose to the Commission the publication of such standards’ references in the Official Journal of the EU (OJEU). In addition, International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) develop standards parallelly to the mentioned EU organisations.

Common specifications for medical devices

The Regulations on medical devices and in vitro diagnostic medical devices refer to “common specifications”. Common specifications are a set of requirements providing means to comply with the legal obligations. For instance, the MDR includes common specifications for products without an intended medical purpose listed in Annex XVI (also known as “aesthetic devices”) as well as for reprocessing of single-use devices. Under IVDR, the Commission has adopted common specifications for certain Class D devices that will become applicable on July 25, 2024.

The Commission can adopt common specifications instead of harmonised standards when there is the necessity to compensate for the lack of harmonised standards or when the ones available are not sufficient in respect of the general safety and performance requirements. Compliance with common specifications is mandatory, unless manufacturers can justify that they have adopted solutions that ensure at least equivalent level of safety and performance

Compared to the version published in 2021, the updated guidance on standardisation for medical devices include the following changes:

(Source: MDCG 2021-5 Rev.1)

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References:

MDCG (2024) MDCG 2021-5 Rev. 1 Guidance on standardisation for medical device. Retrieved on 08/07/2024.