MDCG 2022-5 Rev. 1:Updated Guidance on Borderline Products
11 November 2024
Borderline products are defined by the MDCG as products for which it is unclear whether they are medical devices (MDR Article 2(1)) and therefore fall under the scope of the MDR (EU) 2017/745, or whether they are medicinal products (MPD Article 1(2)) and Directive 2001/83/EC applies. Depending on the classification of the product, only one of the MDR or MPD applies, making the classification crucial for the further approval process, in particular the conformity assessment.
Generally, borderline products are products that also contain a medicinal substance or a medicinal product: If the medicinal product plays a subordinate role in the intended effect and the main effect is not achieved by pharmacological, immunological or metabolic means, the product can be classified as a medical device.
This classification requires objective and scientific justification. MDCG 2022 – 5 (Rev. 1) provides examples and definitions of how to interpret the MDR and MPD to ensure correct application.
The revised guideline adds to section 1.2.6.1 products explicitly intended for cleaning, disinfection and sterilisation of medical devices: Products with this sole purpose are medical devices, whereas multi-purpose disinfectants fall within the scope of Regulation (EU) No. 528/2012 for biocidal products.
The revision of the guideline therefore aims to improve the classification of products and ensure both compliance and patient safety.
If you have any questions about the classification of your product, please contact our experts.
