Medical Device Regulation (MDR)
All medical face masks sold in Europe must conform to Medical Device Regulation MDR EU 2017/745 since May 2021. This European Medical Device Regulation (EU MDR) is a set of regulations that governs the production and distribution of all medical devices in Europe, not just face masks. Compliance is mandatory for medical device companies that wish to sell their products in Europe.
A medical face mask is a medical device covering the mouth and nose providing a barrier to minimise the direct transmission of infective agents between staff and patient. A medical face mask must fulfil the definition as a medical device and therefore have a medical purpose as intended by the manufacturer.
Irema has been compliant with this regulation since October 2019 and was one of the first European face mask manufacturers to become MDR compliant.
MDR compliant face masks must be CE-marked and accompanied by the EU declaration of conformity issued by the manufacturer.