New 2020 lists of harmonised standards

The European Commission adopted revised 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 decision to adopt these harmonised standards for medical devices represents an additional measure taken by the Commission to respond to the coronavirus outbreak.

The titles and references of harmonised standards under Union harmonisation for each of the medical device directives were published March 25^th in the Official Journal of the European Union, L090I.

• Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC  
• Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC 
• Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council 

In addition, The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment (PPE). The standards are available for free download from the websites of CEN national members .