AQW 3433/22-27

Mr Mark Durkan
Social Democratic and Labour Party
Foyle

Tabled Date: 22/09/2022
Answered On Date: 28/09/2022
Priority Written: No

Question:
To ask the Minister of Health what consideration has been given to classifying all dermal fillers as medical devices, in line with protections provided under European Medical Device Regulations, to improve the safety and quality of these products.

Answer:

Under the terms of the Northern Ireland Protocol, manufacturers of medical devices supplying the Northern Ireland market must meet the requirements of the EU Medical Device Regulations (MDR) 2017. These regulations came fully into force on 26th May 2021 and cover certain aesthetic products, including dermal fillers, that are marketed as having no intended medical purpose.

The responsibility for complying with the regulations resides with the manufacturer or their EU-based authorised representative if the manufacturer is located outside the EU.

If the manufacturer is located outside the EU, the importers of the product, who may be the final customer, have certain obligations under the MDR. These obligations include checking that the product has the necessary product certification that confirms compliance with the MDR. If an importer considers that a device is not compliant with the MDR, they must not out put the device on the market. The importer must then inform the manufacturer or their authorised representative, as well as the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for enforcing compliance with the EU MDR in Northern Ireland.