The corona crisis has led to confusion regarding the difference between personal protective equipment (PPE) and medical devices. Just think of the often unclear situation with respiratory masks as an example. 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 affect two different risk groups. The classification is made by the manufacturer. The test procedure of the product also depends on this classification. Both risk groups 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 at times special approvals by the authorities without CE marking, especially under the Medical Devices Implementation Act (this mainly concerned masks for infection protection in the event of a supply bottleneck at the time), it is now the rule that all products are CE marked. It is a fact that false or fraudulent declarations have often been made and falsified certified masks have come into circulation. For safety reasons alone, it is therefore important for the user or entrepreneur to pay attention to the correct CE marking (e.g. for liability reasons), since neither PPE ́s nor medical devices are marketable 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 respirators, 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 this reason, all tests including a type examination are required for such personal protective equipment. These tests are carried out by a certification body ("notified body").
Examples: Particle protective masks are certified according to EN 149, protective clothing against infectious agents according to EN 14126 and protective gloves according to EN 374. After completion of the conformity procedure, the protected product is marked with the CE mark and the identification number of the certification body.
Medical devices
Non-invasive protective products in accordance with Directive 93/42/EEC and the Medical Devices Regulation (EU) 2017/745, which are important in the context of the SARS-CoV-2 pandemic, should be listed here. These products are also divided into risk classes. Risk classes concern low-risk medical devices (risk class I) to high-risk medical devices (risk class III).
For example, medical devices such as mouth-nose protection, masks, medical protective clothing and non-sterile gloves predominantly fall into risk class I. Such medical devices serve to protect patients. As a rule, the preparation of the technical documentation, the declaration of conformity and the CE marking (without identification number) is carried out by the manufacturer for Category I products.
Important examples of products in 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 close examination of the documentation of the protective equipment. In many cases, advice and support from trained staff is recommended. The use of correctly certified protective articles can be essential for survival.