Team-NB asks for regulatory clarity and for manufacturers to not delay MDR applications

Notified bodies (NB) say that while extending the deadline to transition to EU Medical Device Regulation (MDR) has been a positive move, there is more regulators and industry can do to ensure manufacturers can recertify their products on time.

Over the past year, it became apparent to regulators, NBs, and other stakeholders that there was not enough time for many medical devices to transition from the Medical Device Directive (MDD) to MDR. As a result, transition deadlines were extended earlier this year, but NBs argue that more could be done to prevent potential device shortages in the coming years (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023).

“Notified bodies welcome the generous extension of the transition timelines and are confident that they could transition all remaining certificates within the given timeframe,” Team-NB wrote in a white paper published 10 August. “However, it is not just up to notified bodies to facilitate a successful transition.”

Team-NB noted that as the deadline was extended, manufacturers seemed to be showing show less urgency in submitting their applications, and those they were coming in were often incomplete. The group said they currently have more capacity to accept applications and warned manufacturers not to waste the opportunity because as the deadline approaches, there may not be as many resources to review and recertify their products.

“Notified bodies are calling on all manufacturers to liaise with their notified bodies at their earliest convenience and to submit all their applications now to successfully manage this transition together,” said Team-NB. “This would enable the notified bodies to plan accordingly and to spread their resources as evenly as possible over the complete available time.

“Only successful cooperation between manufacturers and notified bodies can avoid challenging peaks in workload towards the end of the new deadlines,” the group added.

Team-NB also asked regulators to speed up NB designations, consider alternative means of proving NB competencies, and help stabilize the regulatory environment by considering the workload new guidances put on them.

On top of the two corrigenda and two amending regulations that have updated the MDR, Team-NB noted that the Medical Device Coordination Group (MDCG) has published more than 80 documents supplementing the MDR that are helpful in guiding stakeholders through the transition. They added that the sheer volume of guidances, however, has been a challenge for NBs because of the resources required to assess and translate them.

“Additionally, crucial guidance documents have become available very late or are still missing,” Team-NB added. “Moreover, some published MDCG documents are not fully applied (e.g. guidance on medicinal consultations not really put into practice by some pharma authorities).”

Team-NB also said that while they are already taking steps to harmonize procedures across the different NBs to ensure predictability, the work is almost completely being done by itself and the Notified Body Coordination Group – Medical Devices (NBCG-Med). The group recommended establishing a technical secretariat that can harmonize the work instead and alleviate the burden on NBs.

Last year, the MDCG published the MDCG 2022-14 guidelines to help NBs and manufacturers as they transition to the MDR. Team-NB says that while there's been significant progress in implementing the document, there are several areas that need to be addressed (RELATED: Convergence: Experts see hope for meeting EU MDR deadlines, Regulatory Focus 12 September 2022).

For instance, the document states that MDCG guidances will be reviewed to eliminate potential administrative burdens, and despite Team-NB sharing around 40 issues with regulators over the guidances, the group said there hadn’t been any significant progress so far.

The group also noted that the document recommends the implementation of the European Databank on Medical Devices (EUDAMED), which has been delayed and led to significant challenges for NBs to meet their MDR documentation requirements. Without EUDAMED, NBs have been feeding data into national databases, which ultimately will have to be transitioned into EUDAMED and lead to unnecessary administrative burdens.

“As these databases are not connected with EUDAMED, notified bodies are bracing for a resource-consuming process to transfer the data once EUDAMED becomes functional,” said Team-NB. “Additionally, the delay of EUDAMED prohibits the chance to derive meaningful insights and learnings from the system.”

“The anticipated advantages of machine-to-machine (M2M) technology, which hold significant potential for enhancing efficiency and analysis, have yet to be realized due to the ongoing delay in the database's deployment,” the group added.

Based on the MDCG 2022-14 guidelines, Team-NB says there has also been no visible progress in adding designation codes to notified bodies or implementing structured dialogue mechanisms.

Team-NB also pushed back against critics who say they aren’t doing enough.

“Notified bodies have been criticized to be insufficiently equipped to fulfill their new regulatory requirements and to not be able to transition the remaining medical device certificates under the directive into the MDR,” said the group. “Notified bodies do not find this to be a justified criticism, as they have taken substantial measures to boost their resources and capacities to meet the increased demands and requirements MDR imposes on them.”

Team-NB argued that NBs have put in substantial resources to hire and train staff while also enhancing their internal processes and operations to meet the transition challenges.

Team-NB position paper

Team-NB asks for regulatory clarity and for manufacturers to not delay MDR applications

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