Progress on CS for Annex XVI products

On 13 October, the European Commission’s Committee on Medical Devices voted on the draft Commission Implementing Regulation on the common specifications (CS) for groups of products without an intended medical purpose, as listed in Annex XVI of the Medical Device Regulation (MDR, 2017/745), copy available from here. The industry group representing manufacturers of these product types has been pushing the Commission to make progress on this issue for some time. At the same meeting, a further draft implementing regulation, reclassifying certain ‘active’ products falling under MDR Annex XVI, was also discussed.

The vote was apparently positive for both drafts, but there is still no indication as to when the final versions of the CS and implementing regulation will be published, although it is anticipated that this will be before the end of 2022.