New coronavirus: Swissmedic issues warning about non-conforming face masks

Medical face masks (also known as surgical or sanitary masks) according to standard EN 14683 are medical devices and therefore have to be CE-marked. An increasing number of non-conforming or only ostensibly conforming medical face masks have started to appear on the Swiss market.

The coronavirus pandemic is increasing demand for medical face masks in healthcare institutions. From market surveillance procedures, enquiries and applications for derogations, Swissmedic has observed that economic operators with no experience in the therapeutic products sector are importing and selling masks. This may result in non-conforming, possibly inferior-quality or even counterfeit products appearing on the market. Non-conforming or counterfeit face masks do not guarantee a level of protection that complies with EN 148683. There are also isolated reports of confidence tricksters failing to deliver products despite a down-payment having been made.

Procurement of medical devices in healthcare institutions – checking medical devices
Swissmedic recommends that healthcare institutions should ignore promotional emails from dubious sources (spam) and procure conforming products through established procurement channels. We recommend that buyers who are considering new providers should thoroughly scrutinise the accompanying documents, verify the sources of the masks on offer and refer to the information in the appropriate Swissmedic information sheet.  

The following information is important for medical face masks (Class I non-sterile medical devices):

• Declaration of Conformity in accordance with Directive 93/42/EEC (or Regulation (EU) 2017/745) by the manufacturer or its European authorised representative
• Details of the European authorised representative (EC-REP) on the packaging if the manufacturer is domiciled outside Europe
• Details of the manufacturer on the product (must be identical to the information in the Declaration of Conformity).

Note: The exemption for non-conforming face masks that the Federal Council approved on 29 April 2020 for inclusion in COVID-19 Ordinance 2 only applies to non-medical uses. Such non-conforming masks must NOT be used for direct patient contact in hospitals or doctors’ surgeries! Since 22 June 2020, these masks must be expressly labelled as not for medical use (art. 23 para. 4 let. b Ordinance 3 COVID-19).

Report non-conforming medical devices
Purchasers of medical devices who notice an irregularity (e.g. potentially counterfeit EC certificates) can report their suspicions to Swissmedic. Swissmedic checks reports of suspicions on the basis of the associated risk and takes corrective action, involving other European authorities where necessary.

The examples below show misleading and counterfeit documents that have no regulatory significance, but are nevertheless submitted as proof of conformity.