September 11, 2022
European Commissioners have published a highly anticipated new version of the Manual on Borderline and Classification for medical devices under the Medical Devices Regulation (MDR) and for in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Version 1 of the new Manual covers qualification and classification of borderline products as medical devices, IVDs, personal protective equipment (PPE), advanced therapy medicinal products (ATMP) and other device types.
Key changes in the new Manual
According to an initial analysis by Emergo by UL consultants in The Netherlands, the new Manual features several significant updates, including:
- New examples of products on the borderline between medical device and IVD; medical device and biocide; medical device and PPE; medical device and food; and medical device and cosmetic product;
- Considerations for ATMPs;
- References to relevant court cases;
- Inclusion of devices and products related to COVID-19 (borderline medical devices, IVDs, biocides and PPE).
No more Manual updates for MDD, IVDD, AIMDD
The European Commission’s Medical Device Coordination Group (MDCG) plans regular updates to the new Manual. It is important to note that Manual information pertaining to the erstwhile Medical Devices Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD) and Active Implantable Medical Devices Directive (AIMDD) will remain available for reference purposes for as long as devices with CE Marking issued according to the Directives remain on the European market. Coverage of Directives-era borderline and classification information, however, will no longer be updated in the new Manual now that the MDR and IVDR have taken effect.