IN-Vitro Diagnostic Regulation (IVDR) – 2017/746 piles on Regulatory pressure and associated costs
In a similar way as the Medical Device Regulations (EU MDR 2017/745) are coming into force on 26th May 2021, IVDR is going through the same transition from Directives to Regulation, with an enforcement date of 26th May 2022.
Again, in a similar manner to Medical Devices, IVD Products already certified by a Notified Body may be placed on the market for a further 2 years under some conditions, such as: any certificate issued under the IVDD will still be valid and subject to surveillance by the Notified Body who had issued it provided no significant changes are made to the product. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).
Many IVD manufacturers will now require a Notified Body to certify their products. Under the old IVDD (directives), 90% of the industry were able to self-certify; under the new regulation, this will be no longer viable. As per the Medical Device Regulation (MDR), there will be far more emphasis on Clinical Evaluations.
The development process for in vitro diagnostic medical devices is complex. The transition to IVDR from IVDD will undoubtedly be complicated and time-consuming for most device manufacturers. Many of the Medical Device Manufacturers transitioning with EU MDR found that they were quickly running out of time – the 12-month delay because of Covid-19 was a lifeline for many. Any IVDR manufacturers should pay heed, that the time to transition is far more onerous than many first thought, and IVDR is more complex.
Explic8 Limited consultants can help you to:
- identify the steps required to transition
- determine the resources required to deliver the transition
- develop a realistic plan to get there
- implement meaningful and demonstrable KPIs to track progress
- identify risks and mitigating actions when issues arise
We can help you succeed, on-time.