Market status by Sue Spencer and Gert Bos

Strange times, with many working remotely, whilst finding a new work-life balance. With several months behind us, we’re getting a little bit used to the new situation. And so do EU’s authorities. They have managed to get quite some guidance out recently, on clinical data requirements, incident reporting, consultations on animal tissue and on combination products, and many more. Such as the updated rolling plan on guidance to be forthcoming; mostly MDR, not a lot of IVDR ahead.

With the MDR Date of Application now being delayed for a year, basically meaning the pressure is off on all parties although the final deadlines have not shifted, attention to the upcoming IVDR timelines are under review as well. The IVDR is starting to gather momentum TÜV SÜD has now been designated so NB capacity has increased and the first findings have started to be issued. There is still a lack of official IVDR specific guidance available but first indications are that as expected there is no light touch for existing devices and that all the expectations of the IVDR including Performance Evaluation Plans and reports have to be met. Even if the IVDR sector is given a years extension creating this documentation for all devices will take time and even with the additional horsepower provided by TÜV SÜD there is still a lack of Notified Body capacity and so it would be essential to get your QMS and dossiers to the Notified Bodies within the upcoming 12 months in order to have a chance of getting certificates to IVDR in time.

Clearly, whatever you chose to do over summer, be it travel abroad or staying close to home, ensure you are rested to push through for MDR and IVDR compliance in the months following the summer break, as it will be defined as the time to make or break……

Gert W. Bos, PhD, Fraps
Sue Spencer
Post date: June 30, 2020
How can we help you? Contact us