In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and classification under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic medical devices Regulation (IVDR). Despite not finalised, this document is of great important for manufacturers as it addresses several borderline areas and example products such as:
- Borderline between medical devices and IVDs;
- Borderline between medical devices and medicinal products, including advanced therapy medicinal products (ATMPs);
- Nasal sprays with COVID-19 antibodies;
- Product for professional removal of dental biofilm.
- Borderline between medical and biocides;
- Borderline between medical devices and substances of human origin;
- Borderline between medical devices and cosmetic products;
- Borderline between medical devices and food;
- Borderline between medical devices and personal protective equipment;
- Rescue bag for patient transport.
- Borderline between medical devices and general consumer products;
- Other medical devices borderlines.
As mentioned, the MDCG Group will provide further examples and information through the Helsinki Procedure in future publications.
To know more about the Helsinki Procedure, you can consult Exchange of information between medical device competent authorities on
borderline and classification cases.
Therefore, this document provides added value to the information already stated in previous classification guidance documents, such as the MDCG guidance on classification of medical devices, the MDCG guidance on borderline between medical devices and medicinal products, the MDCG Guidance on classification rules for in vitro diagnostic devices under IVDR, among others.