According to the latest update to the European Comission'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.

News from the European Commission and NANDO website is that an additional two Notified Bodies (NBs) have now been designated under the Medical Devices Regulation (MDR, 2017/745), but only one of these has yet appeared on the NANDO website.

DEKRA Germany has become the third NB designated under the MDR, with an entry on the NANDO website on 14 August 2019. The fourth NB to be designated is expected to be IMQ, Italy, with entry to the NANDO list within the next few days. These two will join BSI UK and TUV Sud who are already on the NANDO list.

Of course, designation is only the first step towards having NBs that are fully functional under the MDR, so we await information from all of those designated when they will actually be 'open for business' under the new Regulation.

While the doubling of the number of NBs designated for the MDR is good news, the bad news is that with only nine months to go before the Regulation takes full effect, only four NBs have so far been designated. Despite the painfully slow progress in adding NBs to the NANDO list, the European Commission still insists that the Regulation will take effect as planned, with no contingencies. The Commission reports that 52 NB applications have been received and 33 joint assessments have been carried out to date.