The European Commission has adopted decisions on harmonised standards for medical devices, in response to the coronavirus outbreak.

This will allow manufacturers to place on the market high performing devices to protect patients, health care professionals, and citizens in general, the Commission says.

The standards will facilitate a faster and less expensive conformity assessment procedure and will apply to coronavirus-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,” she said.

Technical solutions

Once implemented, the use of these standards will allow manufacturers 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 European Committee for Standardization (CEN) and the European Committee for Electro-technical Standardisation (CENELEC), have also made available a number of European standards for certain medical devices and personal protective equipment.

European standards are part of a fully functioning internal market to reduce costs, promote innovation, ensure inter-operability between different devices and services, and help companies to access markets.

Conformity

European legislation for medical devices also relies on harmonised standards. In particular, under the three current directives on medical devices, there are about 300 harmonised standards conferring presumption of conformity with the legal essential requirements.

The Commission, CEN and CENELEC also agreed on 24 March to make a number of harmonised standards for important medical protective equipment like face masks and single-use gloves freely available to those companies that are willing to start producing these items.