New notified bodies trickle in ahead of looming MDR start date

Dive Brief: The European Commission has revealed the designation of another notified body under the […]

Dive Brief:

  • The European Commission has revealed the designation of another notified body under the incoming Medical Device Regulation.
  • In a presentation posted Wednesday, the Commission disclosed that 12 notified bodies have been designated under MDR and another two have received recommendations from the Medical Device Coordination Group
  • The update shows the Commission is on course to add more notified bodies to its database, but suggests it is still far from establishing the 20-strong body of organizations it once hoped to have in place by the end of last year.

Dive Insight:

The database of notified bodies now features 11 groups designated under MDR and another three cleared to assess tests under the IVD rules. In its latest update, the Commission disclosed that one more notified body has been designated under MDR but is yet to be added to the database.
At 15, the number of notified bodies designated across MDR and IVDR is still five short of where the Commission aimed to be at the end of 2019. The presence of two more notified bodies that have received a MDCG recommendation but are yet designated means the Commission is positioned to bump the total up to 17 in the near term. Yet, beyond that, there is a potential lag.
All the notified bodies to receive final reports and opinions from designating authorities and the joint assessment team have already gone on to secure MDCG recommendations. As such, all of the notified bodies other than the 17 with MDCG recommendations still need to go through at least five steps in the process before they are in the database.
A clutch of other notified bodies are back at the corrective and preventive action submission and review stages. If all those organizations go on to secure designations, Europe will have 23 notified bodies for MDR and another five for IVDR. It is unclear how long that will take, though.
As was evident in the previous Commission update, the submission process is currently the main bottleneck in the designation process. Commission-appointed joint assessment teams have carried out 48 on-site assessments, up from 45 around the start of the year. The latest figure represents more than 80% of the applications filed by notified bodies.
However, the Commission is waiting on submissions from 19 of the notified bodies assessed by JATs. Another notified body withdrew its application at the corrective and preventive action​ or CAPA plan stage. Once the notified bodies submit plans, the Commission can start to move them toward designations, but for now the pipeline is clogged between the on-site assessment and CAPA submission stages.
The ability of notified bodies to get plans to the Commission, and assess devices once they are designated, may currently be hindered by the coronavirus outbreak, which has caused the lockdown of much of the continent. Despite that, the European Union remains due to implement MDR in May, with MDCG making no mention of the coronavirus in its recent update on the current situation.

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