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The use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose. To be precise, the European Commission (EC) has clearly defined the medical face masks and proposed Regulatory options to place them in the EU market with short-term supply feasibility.
According to the definition of medical device, medical face masks act as effective barriers to limit the emission and transmission of infective agents between the hospital staff and patients in medical settings. Distinguishingly, protective face masks or respirators protect against risks, without a medical purpose, and do not meet the definition of a medical device. Likewise, face covers also have no intended medical or personal protection purpose and do not meet the legal definitions of a PPE and a medical device.
Legal Specifications: Medical or surgical face masks fall under Directive 93/42/EEC (MDD), to be replaced by Regulation (EU) 2017/745 (MDR) from 26 May 2021. The filtering face-piece respirators used in COVID-19 context (protective face masks or respirators) are considered as PPE and fall under the scope of Regulation (EU) 2016/425 (PPER). A face covering has no established specific legal requirements and is applicable under the General Product Safety Directive (GPSD) 2001/95/EC.
Classification: According to the Medical Devices Directive (MDD) 93/42/EEC and Medical Devices Regulation (MDR) (EU) 2017/745, medical face masks are classified as:
- Class I – Non-sterile medical face masks: The manufacturer is entitled to carry out a self-assessment conformity procedure, without the intervention of a notified body
- Class Is – Sterile medical face masks: A notified body is required to assess the sterility process and validation of documentation
Regulatory Options: Generally, medical face masks must comply with the MDD and MDR essential safety and performance requirements, along with CE-mark accompanied by the EC or EU declaration of conformity issued by the manufacturer. But, in pursuit of the current health emergency, the following Regulatory options are proposed by the EC to support and scale-up the production of medical face masks.
- Given the complex medical device regulations, leveraging the knowledge and responsibilities of an already established medical face mask manufacturer will be the fastest and least burdensome option for their production. Hence, when the actual manufacturers are legally confined to the MDD and MDR regulations, they can provide their specifications of medical face masks to another producer (sub-contractor), who are currently not working in the medical devices field.
- On duly justified request, the competent authorities of the Member States may authorize specific devices lacking the relevant conformity assessment procedures. The Member State will ensure a short-term supply of these medical face masks by evaluating the documentation for essential patient safety and performance requirements. Post assessment, the authority will decide on the product’s market entry.
- The producers of finished CE-marked medical face masks, who are not the current medical device manufacturers, should comply with all the MDR and MDD legal obligations for market-entry, under their own name. A notified body will assess the sterility process and validate the documents, only if the face masks are supplied in sterile conditions. To import finished CE-marked face masks into the EU market, the legal manufacturer must elect a single authorized representative in the EU to responsibly place the device in the market, by adhering to the compliant European and national Regulatory frameworks.
Taking the accountability of adapting to the aforementioned regulations, the medical face masks’ manufacturers can scale-up their production process through this pandemic crisis. For a compliant market-entry, get a piece of expert Regulatory advice. Stay safe. Stay informed. Stay compliant.
