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.

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.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us

 

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