ABSTRACT

The MDD does not apply to personal protective equipment that is covered by the Personal Protective Equipment Directive.**** In deciding whether a product is a medical device or personal protective equipment, the intended purpose for the product as expressed in the labeling should be considered. The device would be considered a medical device if the product is intended to be used in a medical context with the aim to provide protection for the health and safety of the patient, regardless whether the product also simultaneously protects the user. Examples of protective equipment classified as medical devices or as personal protective equipment are given in Table 15.1.