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 25th 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 .
What does this mean to you?
For in vitro diagnostic medical devices the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standards EN ISO 11137-1:2015 and EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. Manufacturers have until 30 September 2021 to adapt to these revised specifications in the aforementioned standards.
A new harmonised standard EN ISO 25424:2019 has also been adopted.
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