In the wake of the current Covid-19 outbreak, the CE Marking of Surgical masks has become the most asked question on our message board. In response to this, we have looked into the product legislation that covers these items.
As with all CE Marking, one of the key questions when determining the relevant legislation is that of the ‘Intended Use’ of the product; and Surgical masks are no different. there are essentially two pieces of legislation under which they may fall:
If the mask is intended to protect the patient, then the masks would be a Class I Medical Devices under the Medical Devices Regulations. The Regulation does not come into force until May of this year, however there is a derogation allowing it to be used in lieu of the old Directive and as such, we would strongly advise manufacturers to use the new Regulation.
However, the more pressing need for Surgical Masks is for those intended to protect the wearer – In this instance they fall under the Personal Protective Equipment (PPE) Regulations. Under this Regulation, they are classified as Category III PPE and will currently require the involvement of a Notified Body; a list of Notified Bodies can be found here. Although not mandated, best practice dictates that manufacturers should follow the guidance of a Harmonised Standard in order to enjoy a presumption of Conformity to the Regulation. The Harmonised Standard which currently applies to Surgical Masks is EN 149:2001 + A1:2009.
For further help and advice regarding Medical Devices or PPE, please contact the CE Marking Association
Marking Association on 01564 792349
Comments are closed.