According to the latest update to the European Commission’s ‘rollling plan’, the draft implementing act relating to the requirements for organisations that intend to reprocess devices that are labelled by their manufacturers as being suitable for single-use only is now available for public comment until 20 August 2019.
The draft implementing act, titled ‘Single-use medical devices – safety and performance requirements for reprocessing’, has already attracted several comments, most of them very negative, pointing out that the draft significantly exceeds its mandate as provided in MDR Article 17, and includes at least two comments that the draft is so restrictive that it is attempting to implement a ban on the practice ‘by the back door’.
The 14-page document certainly includes many requirements that are not foreseen by MDR Article 17, alongside many others that are already fully detailed in the MDR itself, rendering much of the draft redundant. It will be very interesting to see how this issue is resolved to the satisfaction of all parties.
The comment period has now closed, and you can see all 20 comments on this issue here.