EC Unveils Designating Authority’s Final Assessment Form Under MDR, IVDR

Regulatory NewsRegulatory News | 17 October 2019 |  By 

The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR), which takes effect next May, and the In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022.

The form includes space to describe the assessment carried out by the designating authority and whether all corrective and preventive actions (CAPAs) have been appropriately addressed and, where required, implemented.

Designating authorities can also list non-conformities and their assessments of the corrections and CAPAs proposed by the CAB/NB related to organizational and general requirements, quality management system requirements, and resource and process requirements.

The release of the form is part of a flurry of recent guidance documents from the MDCG, including guidance on the qualification and classification of software under MDR and IVDR, transitional provisions and designating expert device panels.

In addition to questions on compliance, questions still linger on whether there will be enough NBs designated under MDR by next May. Just five NBs have been designated so far.

According to the consulting group Emergo, currently there are 56 NBs designated for the Medical Devices Directive, while at the MDCG stakeholders meeting of 30 September, only 39 of these current NBs are also seeking designation under MDR.

“That means that the future CE Mark certifications for medical devices of 17 Notified Bodies is unclear. Seven of these entities are based in Turkey and Switzerland,” and it’s unclear if the current agreements between the EU and Turkey and Switzerland regarding the directives will remain in place.

Designating authority's final assessment form: Key Information (EN)


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