EU IVDR update, Judith Prevoo, Regulatory Lead – Regulatory Services, BSI
A very informational and interesting, BSI/AAMI International Standards & Regulations Conference, took place on 29 June 2022. The IVDR 2017/746 succeeded the IVDD on 26 May 2022. While the main focus was on the MDR 2017/745 and the transition, as it was fully applicable from 26 May 2021 on, the IVDR 2017/746 related MDCG guidance documents just started to be published.
Under IVDR 2017/745, there will be reclassifications of IV Devices required, and new or extended Notified Body involvement is now mandatory, which is new to many Manufacturers, and IVD Notified Bodies need to evolve and expand, not only for number of reviewers, but also for the newly adopted IVDR passage on competence of Notified bodies.
For Conformity assessment of Class D IVDs, the EU Reference Laboratories have a crucial function under IVDR 2017/746 (Art. 48 (5)) in testing manufactured batches to verify the claimed performance and compliance with applicable Common Specifications, but no Reference Laboratories are accredited at the moment. In case there are no Common Specifications available yet, it also requires a consultation of an IVD Expert Panel, (MDR 2017/746 Art. 48(6), but the establishment of the Panel is also delayed.
MDCG 2021-4 guidance, supported by IVDR 2017/746 Art. 110 (7), suggests proceeding with the certification without the EU Reference Lab verification, until capacities for this are available. This leaves NBs with finding out navigation how to cover the absent Reference Laboratory’s verification for conformity assessment.
The BSI has published a Team-NB Notified Bodies considerations on conformity assessment for class D devices1 via their website, and provided a summary of BSI’s solution2:
Following the statement with Team NB, BSI has now created a working solution to implement the guidance. This will be a risk-based approach, considering the following:
- status of the devices under the IVDD,
- the expectation of a first adoption of CSs, and
- if a device is not expected to have a CS,
- the risk of certification without the involvement of EURLs.”
Additional helpful MDCG Guidance Documents were released:
- MDCG 2020-16 rev.1 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
- MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies
