【奥译言】欧盟新法规IVDR框架下，公告机构短缺的情况日益突出

Survey Highlights Looming Shortfall of IVDR-designated Notified Bodies

Nearly half (46%) of surveyed notified bodies (NBs) recently indicated that they do not intend to apply for designation under the European in vitro diagnostic regulation (IVDR), adding fuel to the contentious issue over the anticipated lack of NB availability to support industry demand.

Team-NB, the European association for medical devices of NBs, conducted the survey “following interest form the sector concerning the designation process in the framework of the IVDR regulation and as an act of transparency.” Results were posted about a week after data collection was completed 11 January.

Out of 32 survey responses, 15 NBs (46.8%) reported they will not apply for IVDR designation. These include nine Team-NB members and six non-members. Team-NB previously indicated that only two members would not apply to be IVDR-designated due to consolidation plans, following a February 2018 survey of its then 22 members.

The new survey results confirm the intentions to apply that 11 surveyed Team-NB members reported last February.

The lack of interest among NBs to be designated against IVDR is further underscored by the survey results around NBs currently designated against the European IVD directive, with 20 out of 22 IVDD designated NBs seeking IVDR designation. These include nine non-members and 11 Team-NB members holding between 50 and 500 IVDD certificates that are currently valid in Europe.

If all 22 of IVDD NBs applied for IVDR status, each NB “would on average need to assess at least 1,600 IVDs,” Merlin Rietschel, MedTech Europe senior manager of regulations and industrial policy, previously told Focus. “This is an increase in notified body workload of 780%, or almost by a factor of eight.”

Yet on IVDR scope, most (8) indicated they were seeking broader scopes than IVDD scopes, followed by six applications for the same scopes as IVDD and three for smaller scopes. New IVDR designations would also result in the scope of two additional Team-NB members covering IVDs for the first time. Further, most (81% or more) of Team-NB members “intended/intend to apply for all codes” to be used for IVDR.

“The results of this survey confirm the intent of the Team-NB members to do their best to allow designation of notified bodies against the IVDR to be as quick as possible and covering all codes,” Team-NB said. BSI, GMED, TÜV SÜD and UL International Ltd are among the 20 members of the association.

Team-NB’s last survey reports on the process for designation against the European medical device regulation (MDR). The data, which was collected between 11 December and 17 December, showed 82% of Team-NB members had submitted their applications to be designated against MDR versus just 40% in IVDR designation processes. This was to be expected considering the 2020 and 2022 transitional periods for MDR/IVDR, respectively. 

The surveys offered insights into the anticipated shortfall of IVDR-designated NBs, though the same scenario is expected to occur with MDR-designated NBs too. TÜV SÜD Product Service GmbH VP Bassil Akra recently indicated that not a single NB was going to be designated last year. This prediction became reality when BSI was informed it became the first NB to be officially designated against MDR earlier this month. MedTech Europe offered certain solutions to challenges with the MDR/IVDR timelines last July.

The European Commission worked to ease concerns last year around the phased-in implementation of MDR and IVDR by releasing a new working plan and a report on the current state of joint assessments on NBs, as well as by discussing questions related to other factors influencing the transitions. Brexit, for example, adds to the uncertainty for device manufacturers to adequately prepare to meet the new requirements. The UK government intends to implement its own version of MDR/IVDR by 29 March.

内容来自：RAPS

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