This is article is outdated: The 19th version of the Borderline Classification Manual became available in April 2018.
The European Commission’s Classification and Borderline Expert Group published a new revision of the “Manual on borderline and classification in the community regulatory framework for medical devices.” This 18th version includes all previously listed cases as well as the following new cases:
1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE – MEDICAL INTENDED PURPOSE
1.19. Products intended to reduce the effect of alcohol
1.20. Radiation shields
4. BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT
4.20. D-mannose for the prevention of urinary tract infections
4.21. Solution of 8-MOP in extracorporeal photochemotherapy
6. BORDERLINE MEDICAL DEVICE –COSMETIC PRODUCTS
6.2. Alum styptic pencils
7. ACCESSORY TO A MEDICAL DEVICE OR AN IN-VITRO DIAGNOSTIC MEDICAL DEVICE
7.5. Microplate washers
8.26. Tissue expanders used in the breast
8.27. Dura guard for use with a craniotome
8.28. Heart bypass cannulae
8.29. Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose
9. SOFTWARE AND MOBILE APPLICATIONS
9.7. Mobile application for managing pictures of moles
9.8. Mobile application for the assessment of moles
Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device but is excluded from the Directives by their scope. Where a given product does not fall within the definition of medical device or is excluded by the scope of the Directives, other Community and/or national legislation may be applicable.
What does this mean to you?
The manual only serves as a tool, the views expressed in it are not legally binding, and only represents the common understanding of the Medical Devices Directive and the In-Vitro Diagnostics Directive between European national Competent Authorities and industry stakeholders. The manual may be referred to in product status or classification rationales, for example.
The manual is focused on the Directives and the definitions and classification pathways set forth therein, thus it has limited value to the Medical Devices Regulation and In-Vitro Diagnostics Regulation.
Don’t hesitate to contact us for more information or for support in classifying your products.