PAGB welcomes the new Medical Devices Regulation

Published on: 5 April 2017


Following the approval of the new Medical Devices Regulation in the European Parliament today, John Smith, PAGB Chief Executive said:

“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.”

PAGB welcomes the new Medical Devices Regulation