The corona crisis has led to confusion regarding the difference between personal protective equipment (PPE) and medical devices. For example, consider the often unclear situation with respiratory masks. Therefore, the protection professionals want to point out the differences between these two risk groups again and explain the differences.
Classification into Risk Groups
Personal protective equipment and medical devices concern two different risk classes. The classification is carried out by the manufacturer. The testing procedure for the product also depends on this classification. Both risk classes require a declaration of conformity for marketability. The requirements based on the applicable rules are very extensive for both personal protective equipment (PPE) and medical devices.
Although there were temporary special permits from the authorities without CE marking, especially after the Medical Device Implementation Act (which mainly concerned masks for infection protection during the then supply bottleneck), it is now the rule that all products are CE-marked. It is a fact that there were many cases of incorrectly or fraudulently declared and counterfeit certified masks in circulation. For the user or entrepreneur, it is therefore important for safety reasons (among others, for liability reasons) to pay attention to the correct CE marking, as neither PPE nor medical devices can be marketed in Europe without a declaration of conformity.
Personal protective equipment
There are risk categories I (low risks) to III (high to fatal risk). The PPE Regulation (EU) 2016/425 of 2016 determines which protective equipment falls into which risk group. For example, corona-relevant protective equipment such as respiratory masks, protective suits, and protective gloves fall into the highest category III.
Contamination could be life-threatening for the exposed person or, in the worst case, even fatal. Therefore, Category 3 protective equipment is required, which also protects against biological hazards. For such personal protective equipment, all tests, including type-examination, are therefore required. These tests are carried out by a notified body.
Examples: Particle protection masks are certified according to EN 149, protective clothing against infectious agents according to EN 14126, and protective gloves according to EN 374. After the conformity assessment procedure has been completed, the protective product is marked with the CE mark and the identification number of the certification body.
Medical devices
Non-invasive protective products according to Directive 93/42/EEC and the Medical Device Regulation (EU) 2017/745, which are important in the context of the SARS-CoV-2 pandemic, should be listed here. These products are also classified into risk classes. Risk classes concern low-risk medical devices (Risk Class I) to high-risk medical devices (Risk Class III).
Medical devices such as face masks, medical protective clothing, and non-sterile gloves mainly fall into risk class I. Such medical devices are intended for patient protection. As a rule, the manufacturer is responsible for creating the technical documentation, the declaration of conformity, and the CE marking (without a notified body number) for Category I products.
Important examples of products from other risk classes: medical gloves are certified according to EN 455, medical face masks according to EN 14683, and surgical clothing according to EN 13795.
The protection professionals always recommend a thorough check of the protective equipment documentation. In many cases, advice and support from trained personnel are recommended. The use of correctly certified protective items can be vital for survival.
