On 29 October 2020, the European Commission published a new version of the Draft standardisation request as regards medical devices (MD) in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices (IVD) in support of Regulation (EU) 2017/746.
Does this mean anything to you? This is the famous document in which the Commission requests a revision of certain existing standards by the European standardisation committees (CEN, Cenelec), in order to adapt them to the new requirements of MD and IVD Regulations, as well as the creation of new standards. As a reminder, the previous version of this document, published in June 2019, had been cancelled on 18 June 2020. It mentioned:
– 57 standards to be revised / 6 standards to be created for MD
– 39 standards to be revised / 4 standards to be created for IVD
The quota of standards planned to be revised or created is now much larger with this new version of the document, which mentions:
– 151 standards to be revised / 28 standards to be created for MD
– 45 standards to be revised / 3 standards to be created for IVDMD
This new request was open for public comment until November 13, 2020. We will therefore know shortly whether it will be adopted as it stands. Stay tuned 😉