Europe – MD et EPI : comment les mettre légalement sur le marché dans le cadre du COVID-19

The purpose of this guidance document is to provide basic indications to allow those
interested parties who are unfamiliar with the regulated sectors of medical devices and
personal protective equipment to identify whether a product is lawfully placed on the
EU market and can continue to be made available, thus purchased and used.
Such clarification has proven especially necessary in the context of the COVID-19
pandemic. The related extraordinary circumstances have rapidly increased the need
and demand for certain devices and equipment: this has resulted in the involvement of
economic operators and other interested parties not previously in the supply and
verification chain of these products. In addition, recent experience indicates the need to
be attentive to misleading or falsified documents as well as to counterfeit products…