Update of the Manual on Borderline and Classification for Medical Devices under Regulations (EU) 2017/745 and (EU) 2017/746
19 September 2025
The fourth version of the ‘Manual on Borderline and Classification for Medical Devices under Regulations (EU) 2017/745 and (EU) 2017/746‘ was published on 12 September 2025.
Compiled by the Borderline and Classification Working Group (BCWG), this manual follows the Helsinki procedure and provides guidance on the classification of medical devices and in vitro diagnostic medical devices. The document contains criteria for determining whether a product qualifies as a medical device or an in vitro diagnostic medical device according to MDR Article 4 and IVDR Article 3, with borderline cases and examples. It also explains the rules for risk classification (MDR and IVDR Annex VIII) based on intended use and characteristics and offers guidance on innovative and combination products.
The latest update adds six new cases to the manual:
These include red blood cell additive solutions containing adenine, a dual-action cream containing menthol and capsaicin, and lactose tablets for vaginal use, which have been included to help define the border between medical devices and medicinal products.
In order to distinguish more clearly between medical devices and cosmetic products, the BCWG assessed microabrasion dental stain removers.
Additionally, the document now discusses medical examination table covers, which are borderline between medical devices and personal protective equipment, and a mobile sterile air system to illustrate the criteria for qualifying as a medical device. Â
These new cases are intended to improve classification consistency and ensure harmonised regulatory application across the European Union. If you have any questions about the classification of your medical device, please contact our experts.
