Where are we with MDR and what do you need to know to be compliant with IVDR?
Just over 4 months on from the implementation of the EU Medical Device Regulation (MDR), there are still manufacturers failing to meet requirements imposed by the new directive. According to a recent article published by The Regulatory Affairs Professionals Society, manufacturers are struggling with concepts of basic UDI-DI, under both MDR which has applied since the 26th of May 2021, and IVDR, which will come into effect by May 2022. It is agreed amongst MedTech organizations that MDR has become a major regulatory challenge, and Kallik has experienced those issues first-hand.
Don't fall at the first hurdle
Bob Tilling, VP Global Sales, who has worked closely with medical device companies in their MDR and now IVDR projects says that the first step towards meeting compliance - organizing the artwork - is possibly one of the biggest challenges. Finding and collating the artwork is the beginning of a long project, and the time it can take to pull these together is often underestimated. Our experience has shown that label content is normally dispersed and stored in different spaces, with some being at agencies or third party suppliers. After getting the content together, it is then necessary to change and update artwork, which, again, takes a lot more time than is generally expected. The delay in starting these projects, along with the belief of it being a straightforward task, is the first step towards missing regulatory deadlines.
What lessons can be learned from MDR and how can we apply them to IVDR?
Similarly to MDR, experts at MedTech Europe estimate that as few as 24% of IVD manufacturers will be compliant by the time the regulation is implemented, with 17% definitely failing to be certified on time. That leaves around 59% of manufacturers with undetermined futures, all depending on what they decide to do in the next few months. Kallik’s Bob Tilling believes that manufacturers must act now to be able to meet the IVDR deadline and avoid the current challenges organizations are facing with MDR, even 4 months on from its initial implementation. Our experience has demonstrated that with MDR, there was not a single company or project that was completed ahead of schedule, even with the 1 year extension due to COVID. Leaving the start of the process to as late as January or February 2022 will result in missing the deadline; the time that is needed to complete the project should not be underestimated. To meet the deadline, medical device companies will need to partner with a labeling and artwork management software company that not only offers technology able to resolve the challenges but also has extensive experience in working in the life sciences industry, particularly medical devices.