This document records the agreements reached by the Member State members of the Borderline and Classification Working Group (BWCG) following the exchange under the Helsinki Procedure under the MDR and the IVDR. This document provides borderline cases and classification cases. Borderline cases are those, in which it is not clear whether a given product is a medical device, or an IVD, or neither. Classification cases are those for which the competent authorities of the Member States identify a difficulty in the uniform application of the classification rules.

In this article, the subjects of the cases will be listed, so that readers who are interested in specific cases, can find the detailed clarification in the attachment.

1. 1. Qualification of medical devices
   1. 1.1 Borderline between medical devices and IVDs
      1. 1.2 Borderline between medical devices and medicinal products, including advanced therapy medicinal products (ATMPs)
         • - Nasal spray with antibodies for COVID-19
           - Graphite crucible
           - Products for professional removal of dental biofilm
   • 1.3 Borderline between medical devices and biocides
     • - Substance for textile treatment
   1. 1.4 Borderline between medical devices and substances of human origin
   2. 1.5 Borderline between medical devices and cosmetic products
   3. 1.6 Borderline between medical devices and food
   4. 1.7 Borderline between medical devices and personal protective equipment
      • - Rescue bag for patient transport
        - Plexiglas box for caregiver protection
   5. 1.8 Borderline between medical devices and general consumer products
   6. 1.9 Other medical device borderlines
      • - Smartphone application for STI prevention strategies
2. 2 Classification of medical devices
   1. 2.1 Rescue bag for patient transport
   2. 2.2 Dermal filler implantable
   3. 2.3 Argon coagulation units
   4. 2.4 Ethylene oxide gas cartridges
3. 3 Qualification of IVDs
   1. 3.1 Borderline between IVDs and medical devices
      • - FeNO measuring device

Attachment: Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

 

 

Reference:
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices