What the European Commission's recommendation on conformity assessment and market surveillance procedures means for manufacturers of face masks and other PPE.
In the context of the COVID-19 pandemic the EU has published a recommendation on conformity assessment and market surveillance procedures for Personal Protective Equipment (PPE), especially face masks, but also gloves, protective coveralls and eyewear protection.
As a Notified Body for the PPE Regulation, BSI is committed to working to support the Commission’s recommendation to ensure that adequate protection is swiftly made available to those who need it most. Our experts have reviewed this recommendation to understand what it could mean for our clients.
The information below contains some key points covered by the recommendation.
Why has the Commission published this recommendation?
Due to the unprecedented levels of demand for PPE in response to the COVID-19 pandemic the European Commission is encouraging Notified Bodies to process applications for CE marking swiftly and to consider non-harmonised standards for certification. This guidance has been given to enable more product to be placed on the market in the EU more quickly. It also aims to reduce the risk of medical professionals and first responders, not having access to the correct or to sufficient PPE.
What does the recommendation say?
For PPE products that are manufactured following technical solutions other than harmonised standards, the World Health organization (WHO) recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions. However, this is only permitted if the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements which are contained in the PPE Regulation (EU) 2016/425.