As we approach the date of application of the MDR next year, medical device manufacturers are focused on ensuring that they get their CE certificates updated and they are able to continue to sell devices into the EU, but the journey isn’t going to stop there. However, the changes in the new regulations are not just about conformity of the product now, and manufacturers need to be thinking beyond simply completing their transition from MDD to MDR.
Most medical device manufacturers are aware of the significant changes that have been made in the Medical Device Regulations (MDR (EU) 2017/745) and In-Vitro Diagnostic Regulations (IVDR 2017/746). Presentations, talks, and training sessions I’ve attended quite rightly focus on the increased emphasis on pre-market clinical evaluation data, post-market clinical follow-up, what registration on EUDAMED will be required (when it happens!) and the inevitable discussion about the limited number of notified bodies currently designated for the new regulations.
However, careful reading of both new regulations uncovers a subtle, but significant shift in the philosophy of medical device regulation by the EU and one that has implications far beyond the transition period.
Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of the regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner.
MDR Article 10, Section 9 (with similar workding in IVDR Article 10, Section 8):
This requires not only that devices meet the design, manufacturing and clinical performance requirements on day 1, but that if safety or performance standards are revised, then the device itself must also be updated. The implicit aim of this and other clauses, is to ensure that products on the EU market are not only safe and effective at launch, but that they also continue to meet state of the art performance throughout the life of the product. This is a significant shift from ‘substantial equivalence’, a term more familiar to the medical device sector.
State of the art sounds scary because when we use the phrase on a day-to-day basis, it suggests hi-tech, cutting-edge technology and performance, and while the phrase appears several times (a quick search indicates 12 times in the MDR), the regulations themselves don’t actually provide a definition for this state of the art. Fortunately that’s covered elsewhere.
State of the art - developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.
The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution.
The state of the art described here is sometimes referred to as the “generally acknowledged state of the art”. [SOURCE: ISO/IEC Guide 63, 3.18]
This helps (a bit), state of the art doesn’t need to be cutting edge technology, but again the implication is that manufacturers will need to ensure their devices keep pace with improvements in technology and clinical practice to keep pace with state of the art whether that means updates to the existing device design or development of the next generation of the product.
This leads to the conclusion that under the MDR/IVDR continuous review of, and potential updates to the device design need to become an integral part of the product life-cycle in order to keep pace with those changes, not only to remain competitive, but increasingly as part of basic regulatory compliance.