New 2020 lists of harmonised standards!

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 .

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.