Where to Begin? Areas to Focus on in Your IVDR Gap Assessment
Currently, only 10-20% of IVDs are subject to Notified Body scrutiny under the IVDD. That number will increase to 80-90% under the IVDR (In Vitro Diagnostic Regulation) and increase the limited number of Notified Bodies authorized to do IVD product reviews.
Below are some of the areas that need your focus and MakroCare can help:
Your existing clinical and performance data will need to be carefully evaluated as this will be required for Class B, C, and D in vitro diagnostic devices (and Class A as applicable). IVDR will entail you to compile a performance evaluation report (PER – see Article 56) for each device, including a scientific validity report, analytical performance report, and clinical performance report. (See Chapter VI & Annexes II, XIII, XIV.)
Post Market Surveillance
Unlike in IVDD (In Vitro Diagnostic Directive), regulators will focus more on vigilance. You need to demonstrate that you have a continuous cycle of process improvement linked to your risk management processes. This includes implementing a follow-up plan for post-market performance. (See Chapter VII & Annex III.)
It is no longer acceptable to merely say that you are complying with EN ISO 14971:2012. The IVDR (In Vitro Diagnostic Regulation) enforces manufacturers to demonstrate that they are collecting feedback continuously and proactively. So ensure your risk management process is adequate
Unique Device Identification
The IVDR will place much greater emphasis on supply chain traceability, and as a result you will need to implement UDI for your IVDs. If you are already doing this as part of US FDA compliance, you know the process, but the format and mechanics will be different.
Quality Management System
If you don’t yet have EN ISO 13485:2016 certification, there’s a good chance that you will need it unless you only make Class A IVD devices under the IVDR. If you are currently complying with the US FDA QSR (21 CFR Part 820) your transition will be easier