On October 7th, 2022, Team-NB, which is the European Association for Medical Devices of Notified Bodies and the Notified Body Coordination Group for Medical Devices (NBCG-Med) (composed of representatives of all notified bodies for medical devices and IVDs) released a new position paper on measures for the verification process for class D IVD medical devices by Notified Bodies (NB) in the absence of designated EU Reference Laboratories (EURLs).
This position paper reviews possible solutions and/or interim implementation measures for Notified Bodies (NB) that would like to progress Class D applications in the absence of EURLs.
It further explores possible solutions for performance verification and verification of manufactured class D devices that could apply until a EURL is designated for the specific category of device under assessment. The chosen solutions may vary depending on the device under evaluation and should be taken using a risk-based approach.
Possible solutions pre-market could be (but not limited to):
For all devices on the market (regardless of whether under IVDD or other jurisdiction)
- Using of sub-contracted labs
- Witness testing during audits
- …
For devices currently on the market under IVDD (or other jurisdiction)
- Use of historic/ QC batch records
- Use of establishes IVDD Annex II List A specifications under IVDR
- …
Possible solutions post-market could be (but not limited to):
Additional measures could be considered by the NB as part of the conformity assessment after initial certification:
- Witness testing at Manufacturer’s site during regular audits
- Proactive PMPF
- …
What does this mean to you?
This paper is of interest to you if you are a manufacturer of class D devices and want to know how the NB would perform assessment of the performance of your device in absence of EURL.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
