In 2017, the European Commission has agreed on and published a new regulatory framework for medical devices to substitute the present Medical Device Directive, thereby increasing the scrutiny on medical device manufactures and supply consistent and practicable rules EU-wide.
In the beginning, the MDR was often understood as a major burden for both established and new medical device companies due the increased requirements for pre-clinical data and post-market surveillance. Originally, manufacturers of medical devices were given a three year transition period until May 26th 2020 to duly adapt their internal processes and products to the new regulation.
During the transition period, however, it became clear that the MDR is not only a challenge for manufactures, but that notified bodies and competent authorities themselves encountered a variety of obstacles as well leading the entire transition onto a rather rocky road. In late 2019, only a small fraction of notified bodies was designated for MDR due to a significant delay within the designation process. The MDCG (Medical Device Coordinating Group) was also way behind their schedule for relevant guidance documents intended to clarify and substantiate the European Commission’s expectations on how to follow the new rules, and the European database for medical devices (Eudamed) seems to be delayed by a matter of years even. And then: Covid-19.
European Comission deciding for a 12 month extension
As a result, the European Commission decided to extend the transition period by one year. This extension period has now reached half time, but still: only 17 out of 48 notified bodies that have applied for designation until recently have actually been designated yet.[1] In addition, although quite a number of guidance documents has been published already, the list of guidance documents under development is constantly growing. While there were 30 MEDDEV guidelines available under the MDD, more than 40 MDCG guidances have been published up to now – some of them have already been revised – and another 36 documents are currently on the schedule.[2] In summary, it appears that a lot of open questions and uncertainties are still to be addressed even half a year after reaching the original MDR-deadline.
Logically, the Medical Device Regulation (MDR) has been the main topic among medical device manufacturers from all divisions for the past years now and with its implementation still in progress, the debate on how the elevated expectations for quantity and quality on clinical data will actually affect the industry still lives on. Of note, the transition from MDD to MDR comes with considerable costs for established manufacturers not only in regard to the time and personnel required for implementing the changes, or the increased service fees from the notified bodies, but especially in regard to the revised general safety and performance requirements (formally: essential requirements). A recent survey from a German EDC service provider indicates that medical device companies spend approximately 5% of their annual revenue for MDR compliance alone.[3] It has thus often been feared that a considerable number of products will drop out from the market – especially those for orphan diseases and rare conditions – for their manufacturers to cope with the rising costs and that innovation of new products decelerates due to this increased level of required clinical data, making the life especially difficult for young businesses and start-up companies.
Our approach at medical magnesium
Being founded in 2015, our team at medical magnesium was faced with the upcoming regulatory changes early on. We implemented the future requirements into our current procedures, anticipated the need for sufficient clinical data on our MDR projects early on and allocated our resources accordingly. This allowed us to dynamically render our process to the respective needs and shift our focus even on short notice. Half-time through the transition, we thus managed to achieve our first main goals as a medical device company on the fly by receiving the CE mark for our first devices under the MDD. Our believe in procedural dynamics and open discussion among all company departments (from development to clinical affairs) allowed us to anticipate the MDR moratorium early on and specifically guide our resources onto certain projects to speed up the process of product validation and certification. As a result, we had been able to draft and submit the complete technical file for our latest mm.X implant, the mm.CS, early before deadline and have finally received the CE mark for our third class III implant.
Being able to achieve these goals during this rather turbulent time of MDR transition and the ongoing health crisis not only fills us with pride. It lets us believe that small business can certainly stand their ground in the MDR regulated medical device market and allows us to face the future confidently.
Author: MG
[1]https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/notifiedbodies_overview_en.pdf
[2]https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf
