EC Adopted Harmonised Standards for Medical Devices to Respond to Urgent Needs

European parliament
25.03.2020 / 18:03

"We have adopted new rules to allow faster and less expensive conformity assessment procedure for medical equipment and products. The new rules also apply to products which are instrumental in tackling the coronavirus crisis," the European Commission announced in a tweet.

Yesterday, the Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure. The revised harmonised standards play a pivotal role in the current coronavirus pandemic because they relate to critical devices* such as:

medical face masks

surgical drapes, gowns and suits

washer-disinfectors

sterilisation

Stella Kyriakides, Commissioner for Health said: “We must not waste a second in our fight against the coronavirus. With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market. This equipment is fundamental for our health professionals – the brave and resilient women and men at the front line - to keep saving lives”.

Once implemented, the use of these standards will allow manufacturers of medical devices and other concerned economic operators, to comply with the health and safety requirements of the EU legislation, taking into account the most updated technical solutions. These standards, once referenced in the Official Journal of the European Union, grant conformity of devices with the requirements of the three Directives on medical devices.

The decision to adopt these harmonised standards for medical devices represents an additional measure taken by the Commission to respond to the coronavirus outbreak. Also upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in cooperation with their members made available a number of European standards for certain medical devices and personal protective equipment.

More information can be found at the European Commission official website: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_522

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