Now that we are approaching Christmas and prepare for the holidays, it’s time to look back on 2017, which will be remembered as the year in which the long-awaited EU medical device regulations were published. With the publication on May 5, 2017 of Regulations 2017/745 on medical devices and 2017/746 on in-vitro diagnostic medical devices, Europe has completed a long legislative process that started in June 2008 with the publication of a document by the European Commission evaluating the functioning of the current medical device directives and providing some provocative suggestions for future change.
Nine years seems a long time to make improvements on the legislative framework for medical devices. Of course, we now have much more detailed requirements, and new requirements are introduced such as for distributors and importers, but the fundamental concepts and requirements have not changed much. Yet, it will have major impact on medical device manufacturers and Notified Bodies alike the coming years, as it takes all those requirements much more seriously than ever before and requires much more work and detail to be compliant. So, it still forms a major event for our sector, which will shape the industry for years to come.
Much of what I have seen this year, reminds me of what happened when the Medical Device Directive 93/42/EEC was introduced and implemented between 1993 and 1998. Then we had a 5-year transition and it would have been much better if we had that also now. Back then, the large multi-nationals started with their preparation 3 to 4 years before the implementation date of 14 June 1998: recruiting additional staff, talking to various Notified Bodies to select the best in terms of competence, service, location and stability, making gap assessments of their systems, setting up submission dossiers and derive a plan to become compliant in time. A large part of the small and medium-size companies waited till sometimes 2 weeks before the implementation date to find out they needed something called CE on their product. And everybody trying to interpret the requirements, as much was still unclear.
We have seen the same happening this year. By now, everybody has heard in some way that new legislation has arrived which will have a significant impact. Qserve has started as early as summer 2016 with the first corporate clients doing gap and impact assessments and is getting every month more requests from mostly large corporations starting the process of preparing for the MDR. Part is still unclear and food for debate, but we learn along the way, building our experience. We bring these experiences together internally across our teams in Europe, US and China as well as through our MDR training events and webinars. In Europe, we held successful training events in Amsterdam with speakers from industry and all the main NB’s about key topics such as Clinical Evaluation, PMCF, Pre-market requirements, quality system impact, supply chain and TF set-up. Similar events were held in California and Israel and we intend to continue these events in 2018 as much is still under debate and we continue to learn from our projects with clients and interactions with various Notified Bodies.
Our smaller clients are now also starting their preparations, often combined with upgrading to ISO 13485:2016 and preparing for MDSAP audits. At the same time, Notified Bodies need to prepare for their application to become designated under the new MDR and IVDR, a process that is about to commence now with the very first NB’s and NBOG having published in November the first policies and forms for the application under the MDR/IVDR. However, we are also seeing that only few NB’s are ready for this task, as they are overwhelmed by the increased scrutiny level they are facing from the Joint Audit Teams, lack of resources, as well as having an increased workload due to a higher compliance level they must push upon manufacturers with associated corrective action work. This leads already to challenges with service levels and timelines to get devices approved, and Notified Bodies not accepting new applications from manufacturers.
All together, these are exciting times to work in our sector. We are all challenged to higher levels in terms of technology, evidence-based science, regulatory interpretations and continuous change. Qserve has grown again the past year to a global team of over 50 quality, regulatory and clinical professionals, who are passionate to help their clients navigate through these turbulent times. We will continue to learn and grow in 2018 with again interesting developments. Most companies will have to upgrade their certification to ISO 13485:2016, more MDSAP audits will occur, the first Notified Bodies will hopefully get their designation under the MDR and IVDR and hopefully ‘Brussels’ will shed more light by bringing out interpretative documents and guidance.
Comparing to the implementation of the MDD in the nineties, I am confident that also this time things will stabilize and we will all find our way in the MDR/IVDR the coming years.
I want to thank all our clients for the trust they have put in Qserve the past year and wish everybody a prosperous and healthy 2018 for their families and businesses.
On behalf of the global Qserve team,
Jan van Lochem, CEO.