The Case For MDR Extension
The Highlights:
Based on current projections, roughly 7,000 out of the 8,120 manufacturer applicants thus far will be issued certificates under the new MDR by 26 May 2024 from one of the 36 approved notified bodies. There are 26 additional applications outstanding still to become a notified body.
For the new IVDR only 268 certificates have been issued out of the 822 applications from manufacturers
The current expiration date of May 2024 and May 2025 will cause a risk of shortage of life-saving medical device for patients according to the European health commissioner.
Both MDR and IVDR have seen a dramatic decrease in overall applicants from MDD/IVDD to MDR/IVDR, dropping from 22,793 to 8,120 under MDR and 1,551 to 822 under IVDR respectively.
The commission has already adopted two acts on 1 December 2022 deferring the timing of the first complete reassessment of notified bodies.
The Commission is considering delaying the transition period depending on the risk classification of a device. Potential new deadlines of 2027 for Class III and Class IIb higher-risk devices and 2028 for Class II and Class I lower-risk devices that require conformity assessments from Notified Bodies
The Commission acknowledges the challenges and opportunities surrounding orphan devices and is looking to potentially create special framework around these devices to continue supplying these life saving devices.
A deeper review:
On December 9, 2022, the Commission met to review and discuss the proposed solutions surrounding the implementation of Regulations (EU) 2017/745 on medical devices (MDR). Charged with the task after the EPSCO health Council expressed serious concerns on 14 June 2022, the Medical Device Coordination Group (MDCG) had to identify the challenges and propose solutions on how to meet the 2024 MDR transition deadline. The MDCG published MDCG 2022-14 stating that actions must be taken to increase notified bodies’ capacity, increase access to notified bodies and other actions to avoid shortage of devices.
In order to increase the notified body capacity, they need to make better use of the audits performed and better use of the auditors time. This includes reducing the frequency of audits required (for re- assessment) and performing hybrid audits to review legacy devices at the time of a manufacturer’s certification audit. Furthermore, make auditors more efficient by developing platforms (i.e., Eudamed) which allow for easier access to documentation, transfer of information and reduces the burden of double registration if possible. MDCG also acknowledges the need for notified bodies to focus on streamlining their internal requirements and increasing personnel training.
To help reduce the confusion for manufacturers, the MDCG asks that notified bodies provide more information upfront about the fees and provide better assistance to first time applicants who are new to the process. They also encourage both manufacturers and notified bodies to engage in more structured, frequent dialogue that helps expedite the process instead of using a more traditional fee-based meeting approach. The relationship between notified bodies and manufacturers needs to be freer flowing and collaborative, where best practices and lessons learned are topics readily discussed at webinars, workshops, and feedback sessions where both sides can learn from each other. This would allow manufacturers to be better prepared for their audits and have a better understanding of how to be MDR compliant. If manufacturers implemented the MDR requirements prior to the required dates, then they would have the time to engage in proactive, honest conversations with their notified body and prevent delay in receiving their certification. Notified bodies would benefit greatly by using this information to help shape future guidance and regulations.
Other actions include the breakout groups: legacy devices, orphans’ devices and medical devices incorporating an ancillary medicinal substance. Each of these areas provides potential opportunities to improve the process by making specific regulations or exceptions for each. Legacy devices have already shown their compliance to the MDD/IVDD regulations and leveraging along with its proven track record on the market will make this the target group for either reduce scrutiny or potential extension on the transition to MDR. Orphan groups have proven to be the most difficult group due to the nature of the devices and should be granted an extension until a more formal structure for transitioning to MDR/IVDR is in place. For medical devices incompatible with an ancillary medicinal substance MDGC calls out the need for expedited review by the medicine’s authorities, especially those already approved under MDD/AIMDD.
The Commission indicated many great efforts have already gone into effect since some of these challenges have been identified but there is a long way to go if they are to avoid an MDR extension.
