Language translations of the IVD and MD Regulation texts available

Posted on 30.08.2016


Translations of the 27 June 2016 consolidated texts of the IVD and MD Regulations are now available. Danish, German, Spanish, Estonian, French, Polish, Portuguese and Swedish versions of the IVD Regulation are available here (see the 2nd entry on this page – all translations should shortly be available). The consolidated text of the medical devices Regulation is available in all 24 official EU languages here (see the 4th entry on this page).

Please note that these are not the official final versions of the Regulations but simply translations of the 27 June text which comes out of the Trilogue agreement. However, while some typos/inconsistencies in the texts will be fixed, these versions are expected to be extremely similar to the final text of the IVD and MD Regulations which are expected to be published in early 2017. A political process will take place over the next 6-8 months to review the texts (for minor inconsistencies) and formally adopt them.