22/11/2024

In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, entitled ‘Guidance on borderline between Medical Devices and medicinal products under Regulation (EU) 2017/745 on Medical Devices‘.

This guideline is a key reference point in the European Union for clarifying the regulatory distinctions between Medical Devices and medicinal products. This guideline helps the manufacturer to correctly classify borderline devices, which are those products that by their nature do not immediately relate to a specific sector, for which it is therefore difficult to define which regulation should be applied. In particular, the document refers to devices on the borderline between Medical Devices and medicines.

Main Updates

MDCG guideline 2022-5 rev. 1 retains its importance in helping manufacturers and regulators determine whether a product should qualify as a medical device under MDR (EU) 2017/745, or as a medicinal product under Directive 2001/83/EC and Regulation (EC) No. 726/2004.

In the October 2024 revision, specific updates were made to Section 1.2.6.1, concerning products intended for cleaning, disinfection or sterilisation of Medical Devices.

The revision clarifies that products specifically intended for the cleaning, disinfection or sterilisation of Medical Devices can be classified as Medical Devices, according to MDR (EU) 2017/745, if they are used as part of the preparation of the devices themselves. However, if the manufacturer has not specifically and solely intended them for such purposes (e.g. in the case of multi-purpose disinfectants), they are not covered by the Medical Device Regulation (MDR). The latter are instead covered by Regulation (EU) 528/2012 on biocidal products, which applies to products with a broader, non-specific use.

The distinction is based on the main action of the substance involved and the manufacturer’s declared intent. If the action is primarily pharmacological or chemical, the product is considered a medicinal product; if, on the other hand, the action is ancillary or supportive of a device, it is considered a medical device.
In the case of cleaning, disinfection or sterilisation products, to be considered Medical Devices they must have the sole intended use of preparing other Medical Devices.

Impact on Companies and the Sector

The updates have direct implications for manufacturers, as they clarify the conditions under which a product is considered a medical device and not a biocidal product. This is particularly relevant for companies producing detergents and disinfectants for specific uses in Medical Devices.
The clarification provided by the updated guideline will help facilitate manufacturers’ compliance with MDR requirements.

The full version of the guide is available on the official website of the European Commission and can be consulted at the following link: MDCG 2022-5 Rev. 1 – Guidance on borderline between Medical Devices and medicinal products.

For more information on Borderline substance-based devices, read the article on our Blog.

>>> THEMA, in collaboration with other Complife Group companies, offers integrated and comprehensive support for regulatory compliance and quality management of Borderline Medical Devices, particularly when supported by a medicinal product with ancillary function. For more information on the Borderline Service, please contact sales@complifegroup.com.