SARS-CoV-2 virus protection products - are they subject to certification?

In recent days, we have been receiving many questions from the market about the certification of products for protection against the SARS-CoV-2 virus causing Covid-19.

We wish to inform that not all products used to fight the virus are medical devices and are subject to certification.

However, the ones which are medical devices, in accordance with the Act of 20 May 2010 on medical devices, for the most part should be classified as Class I or Class I sterile medical devices.

Class I devices, such as some of the protective face masks, are not subject to certification by designated Notified Bodies. But, if they are medical devices, they must meet the requirements of the abovementioned Act.

Class I sterile medical devices and higher classes (IIa, IIb and III) are subject to obligatory certification, e.g. respirators which fall in Class IIb.

The same applies to the certification of diagnostic tests used to diagnose a virus infection. The SARS-CoV-2 tests, intended for use by professionals in diagnostic laboratories, are not subject to certification by the Notified Body. But the ones generally available – intended for self-testing – should be assessed by the Notified Body and should have certificate of conformity issued by this NB.

It is important that all medical devices meet the applicable legal requirements specified in the abovementioned Act as well as in relevant Regulations of the Minister of Health:

– for personal protective equipment (e.g. masks) and other products used to fight the virus or to save life (respirators) during a pandemic is the Regulation of the Minister of Health of 17 February 2016 on the essential requirements and procedures of  medical device conformity assessment,

– for diagnostic tests (for professional users as well as for self-testing) is the Regulation of the Minister of Health of 12 January 12 on the essential requirements and procedures of in vitro diagnostic medical device conformity assessment.

Additionally, on the official Gov.pl portal, where examples of products used to fight the SARS-CoV-2 virus are provided, you can find detailed guidelines as to the requirements that these products must meet to be effective in their operation and can be used safely in fight with the virus.

If you have questions and doubts regarding the certification of medical devices used to fight the virus, please contact the Director of the PCBC Medical Devices Certification Department Adam Sobantka, tel. +48 663 484 845.

We also encourage you to visit the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – http://www.urpl.gov.pl/pl/wyiarki-medyczne-1 to refer to the rules for submitting notifications and notices to the President of the Office about medical devices.