The FAMHP issues guidelines for checking the compliance and suitability of surgical face masks The guidelines are for companies not producing in accordance with European standards and for healthcare establishments and authorities ordering the masks.
The COVID-19 pandemic is generating enormous demand for medical products, particularly face masks. The increase in global demand is putting pressure on the supply chain for these products.
It is essential for products, wherever they come from, to be of the required quality and quickly available for those who need them. By respecting European regulations and standards, medical devices can be marketed properly with a maximum guarantee of quality, safety and efficiency.
However, given the exceptional circumstances, products for which an equivalent level of safety and performance can be demonstrated are currently authorised temporarily.
In order to help companies that do not adhere to European standards in the production of surgical face masks to meet the minimum requirements in the current circumstances, guidelines have been drafted to check the conformity of products. Public authorities, healthcare establishments, etc. can also use these guidelines.
Importers of medical devices do not need an import licence for this and do not require registration on the FAMHP web portal.
The conditions which the personal protection equipment must meet (for example the FFP2/FFP3 respirator masks) can be consulted on the FPS Economy, SMEs, Middle Classes, and Energy website.