On 27 September 2023, the Medical Device Coordination Group (MDCG) released an update to its manual on borderline and classification of medical devices under Regulation (EU) 2017/745 relating to medical devices and Regulation (EU) 2017/746 in respect of in vitro diagnostic medical devices.
The updated manual reports and explains the basis of the decisions of the Borderline and Classification Working Group (BCWF) relating to the classification of the following products:
- Root canal irrigation solutions containing sodium hypochlorite (NaOCl) or chlorhexidine digluconate (CHX) are to be classified as class III medical devices unless the manufacturer can provide robust scientific evidence that the NaOCI and CHX in these solutions have no antiseptic or antibacterial purposes in or on the human body or its constituents.
- Temperature sensors embedded in orthopaedic devices for patient compliance tracking are not to be regarded as an accessory to a medical device, nor should they be regarded as a medical device on its own.
- A system intended to produce sclerosing foam is not to be classified as a medical device, however, if the manufacturer of such a system included in it a CE-marked syringe which is intended to dispense the foam, the system would meet the definition of a procedure pack.
- n-butyl-2-cyanoacrylate (nBCA) based adhesives, intended for the permanent endovascular closure of the great saphenous vein and associated varicosities, are to be classified as class III medical devices.
- Custom-made cranial implants, intended as a replacement for parts of the skull, are to be classified as class III medical devices.
Conclusion
For more details, please contact Margaret Muldowney, Mary Cooney or your usual William Fry contact.
Contributed by Joanne Poland
