SURGICAL / PROTECTIVE MASKS have their own product classification and detailed obligations related to their admission to the market and their export. The last entry, if it concerns domestic production, refers to the regulation of March 11, 2020, when surgical masks (and other items of medical personnel clothing) were included in the list of products at risk of unavailability in the territory of the Republic of Poland. This results in specific procedures related to their transport abroad.

The topic of surgical masks / protective masks has become a key issue in discussions and regulations arising from the need to use them during a pandemic and the introduced epidemic state. These issues are extremely important for both producers and customers who pay attention to the standards applied in them and the quality confirmed by tests.

Surgical masks / protective masks are subject to a dual product classification based on their roles and intended use which meet:

1. Protection of patients and third parties;

2. Protection of medical personnel.

The above purpose often results in a double legal classification of the product, treating it as a medical device or as a personal protective equipment.
According to the definition of a medical device, Art. 1 point 38 of the Act of 20 May 2010: is “another article, used alone, intended by the manufacturer for human use in order to prevent a disease that does not achieve the intended effect in the body or on the human body by pharmacological, immunological or metabolic means”.
According to the definition of a personal protective equipment, Art. 3 sec. 1 lit. a of the Regulation of the European Parliament and of the Council (EU) of 9 March 2016, is “a measure designed and manufactured to be worn by a person for the purpose of protection against one or more risks to the health or safety of that person”.

Surgical masks / Protective masks have a specific product category and class. This is due to the necessity to meet the requirements specified for the categories of medical devices and those specified for personal protective equipment, which in practice means carrying out the conformity assessment procedure, which depends on the class / category to which the product has been assigned.
It is necessary to meet both the requirements specified for a given category of medical devices and those provided for the appropriate category of personal protective equipment.
A surgical mask / protective mask is by definition a class I medical device, marked as: “non-invasive medical device, subject to rule 1 among the rules provided for in the Regulation of the Minister of Health of November 5, 2010 on the classification of medical devices”. The assessment of its conformity does not require a certificate of a notified body, the assessment is performed only by the mask manufacturer.
On the other hand, personal protective equipment of category III, defined as “a product that protects the wearer against dangers that may have very serious consequences, such as death or irreversible damage to health, related to harmful biological agents”, requires conformity assessment by a notified body.

The manufacturer of the protective masks issues one declaration of compliance based on the met and confirmed essential requirements for the product. The declaration must include information on compliance with the requirements for both medical devices and personal protective equipment. The CE marking should be placed on the packaging assigned to the product, accompanied by the number of the competent certification body that issued the conformity assessment.
Many manufacturers use the harmonized standard in the description of their products EN 14683 (in Poland as PN-EN 14683 + AC: 2019-09 – Medical masks – Requirements and test methods), which is to be synonymous with meeting the essential requirements. This does not apply to masks intended for the personal protection of medical personnel.

There are a number of notification requirements before the surgical masks / face masks are placed on the market. A dedicated unit is the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), which accepts listings and notifications. The documentation should be prepared in writing by completing the form available on the URPL website, the form should also be downloaded and signed. We attach the remaining documentation to the signed printout and submit it in paper form and recorded on an electronic medium to the President of URPL. What is important when filling in the form – it cannot be edited. Personal protective equipment intended for the protection of medical personnel does not require notification.
The date and scope of the documentation submitted to URPL depends on several factors:
Manufacturer based in Poland – submits the notification at least 14 days before the product is first placed on the market.
The same applies to a manufacturer based outside the EU, who is represented by a notifying entity designated as its authorized representative in the EU with its seat in Poland – submits the notification at least 14 days before the first placing on the market;
The manufacturer is based outside the EU, and the notifying entity is the importer of the product and has its seat in Poland – notifies URPL within 7 days from the date of the first introduction of the product to the territory of Poland for distribution;
A manufacturer based outside the EU, whose notifying entity is a distributor of the product and has its seat in Poland, operates in a similar way – notifies URPL within 7 days from the date of the first introduction of the product into Poland for distribution purposes.
How is a notification different from a notification?
The manufacturer and the authorized representative shall submit the notification. The distributor and importer use the form of notification.
The notification entails the provision of more information than is the case with the notification. In addition to basic data, we must complete the documentation, among others o generic name of the product, product description, application, class, applied classification rules, number of the notified body.
In connection with the current pandemic, a URPL message of March 17, 2020 was issued saying that the label “concerns the SARS-CoV-2 coronavirus” was used at the top of the first page of the documentation. Documents submitted with this annotation will be considered first.
From May 26, 2020, the provisions of the new EU regulation on medical devices also apply, facilitating their placing on the market only on the basis of information containing the name of the product and contact details of the person to be processed, sent by e-mail to the following e-mail address: wyroby-mdr@urpl.gov.pl
The conformity assessment carried out must confirm that the requirements provided for by this regulation have been met, only then the product may be marketed and distributed without the need to submit notifications / notifications, until the Polish legislator adopts national implementing provisions to the EU regulation.
The pandemic has also changed the export of many medical devices, making them a scarce commodity. From March 11, 2020, surgical masks (and other items of clothing of medical personnel) – were included in the list of products at risk of unavailability on the territory of the Republic of Poland, therefore, export or sale outside Poland requires notification to the General Pharmaceutical Inspector, who in the face of shortages of medical devices may prohibit their export from Poland.