ARTICLE SUMMARY:
In a recent update, the MDCG puts pressure on notified bodies and renews calls for “structured dialogue". Excerpted from Pathways’ Picks December 6: EU Roundup, Medicare Snags, LDT Input Rushes In.
The European Medical Device Coordination Group updated a controversial 2022 position paper (MDCG 2022-11) last week to broaden its scope, calling for quicker action under EU regulations to notified bodies and not just manufacturers. In the original document, MDCG put manufacturers on notice to “ensure timely compliance with the MDR requirements,” which some in the industry viewed as unfairly laying the blame for system-wide Medical Device Regulation implementation failures on companies. The revised document adds a new section urging notified bodies to “streamline their procedures and make all needed efforts to improve their conformity assessment activities in terms of transparency, timelines, predictability and consistency.” The updated doc reiterates its call for manufacturers to send in applications as soon as possible, and expands its focus to the IVD Regulation (IVDR), warning of feared bottlenecks for high-risk (Class D) IVDs in 2023. It also newly acknowledges the “effort of the many manufacturers that already adapted their system to the Regulations.”
In the updated position paper, MDCG also “reminds notified bodies to organize structured dialogues with manufacturers” as a means to streamline conformity assessments and prevent incomplete applications. The group first spotlighted the possibility of structured dialogues as a mechanism for notified bodies to offer extra input and assistance to companies prior to and during MDR/IVDR conformity assessment last year. But the bodies have been wary of offering extra advice because there is too much ambiguity about where to draw the line between appropriate engagements and illegal consultancy. TÜV SÜD was the first to roll out an official structured dialogue offering this fall. In unveiling the service, the large notified body underscored that the dialogue “shall be ordered independently from the MDR/IVDR framework agreement.” Notably, in the revised position paper this week, MDCG suggests the dialogues are “expected to be part of the normal pre-application and conformity assessment activities and therefore not to be a separated service to be charged for.” For more on the structured dialogue issues, see “Can We Talk? Breaking Down Barriers to Notified Body-Manufacturer Dialogue,” Market Pathways, November 30, 2023.)