It’s not the easiest to understand all the certifications and directives that personal protective equipment (PPE) and medical devices require. There are many different types of products, in different materials with different degrees of protection for different areas of use, which all effect which certificates and directives they need. All personal protective equipment must be certified and tested in accordance with current EU directives. Protective products are designed in accordance with EU-established EN standards. The standards have been developed to provide increased quality and safety for the wearer. These EN standards are an extension of the following EU directive on personal protective equipment:
The purpose of the product is what determines whether the product is covered by the rules for medical devices or personal protective equipment. In general, products intended to protect the patient are regarded as medical devices, while products intended to protect staff are counted as personal protective equipment. However, this is decided on a case-by-case basis and the manufacturer must state the intended use of the product. Personal protective equipment can be used in both healthcare and other contexts, while medical devices are intended for use in healthcare.