EU Commission Guidance Update: Placing Medical Devices and PPE Lawfully on the Market in the Context of COVID-19

News Category: Regulatory news

Date: 03/06/2020

In response to the rise in new economic operators producing medical devices and PPE, the European Commission has published guidance on the placing (and making available) of these products on the EU market.

As noted in this document, extraordinary circumstances have led to a rapid increase in the need, and demand, for specific devices and equipment. This has resulted in the involvement of economic operators (such as importers, distributors and manufacturers) who were not previously involved in the supply of these products.

The document is available to download from the website of the European Commission. It may be useful to new economic operators in these areas.

The HPRA is the competent authority for medical devices. However, queries pertaining to PPE should be directed to the Health and Safety Authority.

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