By the 2007/47/EC which came into full force as of March 21st 2010, face masks may have to comply from with the essential safety requirements of the MDD 93/42/EEC as Class I medical devices AND also with the essential safety requirements of the PPE 89/686/EEC.
The EU Commission “categorization guide” on PPE 89/686/EEC specified in its explanation of category 7.3 that “surgical masks” were excluded of the scope of the PPE 89/686/EEC but added as a footnote (3): “Where such masks are intended to protect the wearer against microbial and viral infections, etc. they are in certification category III (personal protection rather than medical use).
The MDD 93/42/EEC as amended by the 2007/47/EC is stating now in its article 1,6: “Where a device is intended by the manufacturer to be used in accordance with both the provisions on Personal Protective Equipment in Council Directive 89/686/EEC (1) and this directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.”
For instance, surgical masks being used for patient protection (MDD Class I) and protection of the practitioner using them (PPE category III) and risking infection from the patient during intervention.
For surgical masks that have no particular claim like a protection of the wearer against infectious diseases such as HIV contaminated blood or viruses (coming from the patient, in that case the mask will become a PPE category III), the surgical mask will have only to comply with MDD 93/42/EEC as amended by the 2007/47/EC under the scope and definition of a medical device.
A MEDDEV (for Medical Devices), as commonly named, is a EU Guidelines document aiming to promote a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with Market & Public Health Vigilance.
MEDDEV are drafted through a process of consultation with various interested parties during Expert meetings (e.g. MDEG) drafts are circulated and comments are exchanged were taken up in the documents. They reflect positions adopted by representatives and experts of EU Member States Competent Authorities, EU Commission Services, Notified Bodies, Industry and other interested third parties involved in the medical devices field.
These guidance documents are not legally binding.
Due to the participation of all the above mentioned parties in the elaboration of these guidelines, it is expected that they will be followed by the Member States and, consequently, will enable a better harmonized application of the relevant Directives requirements. MEDDEV documents, as such, are subject to regular updates.