Question 6
As a Manufacturer (MFR), which obligations of the IVDR do I need to fulfil in order to place an IVDR compliant device on the market before the Date of Application (DoA) according to Art. 110 para 5 IVDR?
Answer
As many obligations as are possible, while taking into account that
- EUDAMED may not be fully functional and
- the IVDR is not fully applicable
at that point in time.
Generally speaking, that is to say that:
- first, the device as such needs to be IVDR compliant (see Annex I IVDR) and
- second, the MFR has to comply with the IVDR.
In particular, the MFR shall undertake an assessment of the conformity of that device in accordance with the applicable conformity assessment procedures set out in Art. 48 IVDR. This may, depending on the risk class of the device, necessitate the involvement of a notified body designated and notified in accordance with the IVDR (see Art. 110 para 6 IVDR).
The following requirements of the IVDR need to be fulfilled by the MFR (non-exhaustive list):
- performance evaluation
- risk management
- QMS
- Post-market surveillance
- Technical documentation and other reports
- Liability for defective devices
However, exceptions/adaptations are possible/necessary, particularly due to the fact that EUDAMED may not be fully functional before the DoA. For example: