“We welcome the new Medical Devices Regulation and in particular the recognition within that of substance-based medical devices, which have a physical, rather than pharmacological mode of action.
“These are important products whose continued availability will enable people to effectively self care for their self-treatable conditions.
“Together with the Association of the European Self-Medication Industry, AESGP, we are now calling for a proportionate and consistent approach to the implementation of the Regulation.
“In the last year, PAGB has developed a Self Care Medical Device Advertising Guideline for our members and we are working on a phased advertising submission period. By January 2018 all public advertising for substance-based self care medical devices by our member companies will require pre-approval by PAGB before publication or broadcast.
“PAGB believes that the new Medical Device Regulation marks the gold-standard for regulation and looks forward to working with the Medicines and Healthcare products Agency and Notified Bodies on its implementation in the UK.”
