Coronavirus: harmonised standards for medical devices to respond to urgent needs
Stella Kyriakides, EU 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”.
Brussels, 25 March 2020
European Commission - Press release
On March 24, 2020, the Commission adopted decisions on harmonized 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 harmonized 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
Background
European standards are an essential pillar of a fully functioning internal market. They reduce costs, promote innovation, ensure interoperability between different devices and services, and help companies to access markets.
To support EU product legislation, the Commission can request the development of European harmonized standards to facilitate compliance by manufacturers of the relevant requirements. Once agreed and referenced in the Official Journal of the European Union, these harmonized standards become part of EU law and allow companies an easy and direct access to the internal market for their products, while ensuring a high degree of safety for users and consumers.
European legislation for medical devices also relies on harmonized standards. In particular, under the three current directives on medical devices, there are about 300 harmonized standards conferring presumption of conformity with the legal essential requirements. The Commission and the concerned European standardisation organisations (CEN and CENELEC) continuously work together to update and improve the set of harmonized standards available to economic operators in the EU.
In such a common effort to face the coronavirus pandemic, the Commission, CEN and CENELEC have agreed to make a number of harmonized 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.