Surgical gown as a medical device

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Surgical gown as a medical device

The development of the COVID-19 pandemic increases interest in the medical devices market. In addition to medical masks and diagnostic gloves, gowns are another popular group of medical devices that are part of medical clothing. There are many models of barrier aprons on the market. It is worth noting, however, that, as in the case of masks, there are clear differences between aprons being a medical device and a personal protective equipment (PPE). The most important difference is, of course, the declaration of conformity, which applies to other legal acts. In the case of medical devices, we are talking about a declaration of compliance with Directive 93/42 / EEC or, increasingly, also the MD Regulation (EU) 2017/745. In the case of PPE protective clothing that covers or replaces personal clothing and protects against one or more risks, we are referring to products that fall into category II or III PPE. Among other things, for the above reasons, the PPE protective clothing is subject to mandatory certification for compliance with Regulation 2016/425.
In the case of medical devices, surgical gowns are classified as class I, the conformity assessment of which is carried out by the manufacturer and not the certification body. However, it is important during the conformity assessment to be sure that the material, i.e. the raw material from which the apron is made, has been tested for compliance with the PN-EN 13795-2: 2019-05 standard and the production itself is carried out in a manner supervised by the quality management system. The requirement to implement a management system is related to the Regulation 2017/745, planned to be introduced in 2021, therefore the issue of implementing such a system should be considered now.
It is also worth emphasizing that there is a fundamental difference between a disposable medical / surgical gown and a sterile one. Medical / surgical gowns are classified as class I, i.e. the manufacturer himself performs the conformity assessment. In the case of sterile gowns classified as sterile class I, the conformity assessment is carried out by a notified body. This extends the process of introducing a given product to the market and significantly affects its final cost.

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