While recent information shows that both Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications have been on the rise, there are concerns as to whether the Notified Bodies have the capacity and competency to accommodate this trend.
In March of this year, the EU commission released Regulation (EU) 2023/607, with immediate effect. This document outlines the deadlines for transitioning from the existing new approach directives (e.g., MDD, IVD, and AIMD) to the MDR and IVDR with the objective of managing the potential risk of device shortages on the market. Manufacturers are being given some flexibility to continue placing their existing CE marked devices on the market based current compliance based on previously issued certificates while they make these transitions. Having said that, conditions still apply to which devices are allowed to be considered in this transition effort.
The timelines are not the only hiccups affecting a smooth transition as manufacturers and Notified Bodies are both learning through this process. One of the major challenges with the implementation of the IVDR, in particular, is the fact that due to the reclassification of the devices from the existing IVD, many manufacturers which were previously able to self-declare, are finding themselves having to deal directly with a Notified Body where they may not have. An estimated 70% or more will be faced with direct interactions with a Notified Body which presents a substantial learning curve as they try to navigate both the quality management system and technical requirements.
Because of this increase in new manufacturers requiring Notified Body oversight, there is also the issue of device volume. The amount of devices this represents is on the order of a six-fold increase to what was once self-declared under the IVD. This directly translates to Notified Body competency being strained. Building on the fact that those devices would now need auditor/reviewers with the training, skills, knowledge, and experience to properly assess them, the Notified Bodies have found themselves urgently searching for resources. To add to that urgency, the Notified Bodies must have ‘permanent availability of sufficient administrative, technical, scientific and clinical expertise’ or more simply put, they must be fully employed by the entity, not contracted.
All devices are coded, both vertically (based on design and intended use) and horizontally (for technical specifications), which means Notified Bodies need to ensure they have the resources that possess (particularly the vertical) the codes that match the device being assessed and to which the Notified Body has been designated. Comparatively, under the IVD, coding was less prescribed, whereby staff with a vertical code were awarded competency in a specific category (possessing multiple codes) which, while reducing the expertise, saved on resources.
A direct side effect is that the amount of audits now increases, in turn forcing the depth and extent of the audits to increases, and therefore, the need for increased technical experts increases. Where once a technical expert could account for multiple competencies, audits or project assessments may now require multiple experts, further compounding the strain on the Notified Bodies.
Another factor in the availability of Notified Body resources is the designation process itself, which has been very slow. Under the IVD, there were as many as 39 Notified Bodies that could cover the device codes. Under the IVDR, the number of designated Notified Bodies has dwindled to 10. A result of this may be the need for manufacturers to use several Notified Bodies to cover their portfolio of device codes or in some cases, weigh the option of waiting until their Notified Body is eventually designated. It has been seen that due to the overall complexity of the compliance process, manufacturers’ applications are often refused as a result of not being within the scope of the Notified Bodies’ designation or due to incorrect classification of the devices. This could also cause manufacturers to slow their progress to market because they would be forced to work in smaller volumes to give the Notified Bodies time on their work plans.
We must also consider the ripple effect of the global regulatory timelines. As the EU rolls out these regulations, the Medical Device Single Audit Program (MDSAP) was also in full effect, bringing with it the need for recognized Auditing Organizations. These AOs are the very same entities that are vying for EU designation with their already limited resources.
The take home, ensure a clear understanding of the path toward compliance with the regulations to reduce or eliminate costly (and time consuming) mistakes and maintain effective communication with your Notified Body to ensure they are aware of your plans for transition.
