Testing of Surgical Masks in EU

Today, the European Commission called out to the UK testing industry with an urgent request in response to the Coronavirus outbreak. They would like to find out the capacity of conformity assessment bodies in the UK to conduct tests on surgical masks in the EU.

The Commission is asking for this information to support manufacturers of other products who recently converted to developing and manufacturing surgical masks to address the increased demand. These manufacturers are either unable to conduct the testing on their own or consider testing a blocking process to entry on the market.

In particular, the surgical masks are subject to the scope of the Medical Devices Directive – Council Directive 93/42/EEC, to be replaced by Regulation (EU) 2017/745 as of 26 May 2020.

The relevant harmonised standard is EN 14683. This is now made available for free, following the EU’s response to COVID-19.

EUROLAB will aggregate the information. To respond to the request, please complete this form, and send to the EUROLAB Secretariat ([email protected]) as soon as possible. It also includes a question about testing capacities outside of the EU in order to provide the Commission with as much detailed information as possible.

This form can also be used to raise any ongoing issue regarding testing and accreditation to the Commission.

The European Cooperation for Accreditation (EA) has also published today a communication which includes a list of accredited laboratories for testing of surgical masks.