The In-Vitro Diagnostic Regulation (IVDR) was introduced by the EU to replace the In-Vitro Diagnostic Directive (IVDD). Under the Directive, most IVD products were self-certified. The IVDR is going to change all that with a new risk based classification system, many now need notified bodies for CE marking. In addition, the UK left the EU and is in a state of regulatory limbo. IVDs will be regulated under the new UKCA however what this looks like is unclear.

We interviewed our IVDR trainer, Richard Young, to discuss these major issues and to get some valuable insight. Richard provides answers to the following questions

What  is changing in the IVDR?

The IVDR is very different to the IVDD. The new IVDR is a very different beast and is very closely aligned to the Medical Devices and the MDR. There is greater emphasis on risk based classifications.

What is happening with the transition period?

This will be a great relief for all involved as there is poor Notified Body resources for IVDs. There is a shortage of NB for medical devices, and even shorter for IVDs. Previously 80% of IVDs did not need a NB. Under the new IVDR, 80% will require a NB which is a big change. The transition dates are dependent on the IVD classification with the high risk IVDs being shorter. Manufactures will need to use this extended time to implement the changes as they are quite big.

Could you share some insight on major IVDR changes in in the areas of Notified Bodies, risk classification and performance data.

The Notified Bodies are getting increasingly involved. IVDs are very important things and the regulation has been adapted to reflect their importance. As mentioned, many products will now be scrutinized by Notified Bodies.

There is a new risk based classification based on the impact of the diagnostic outcome to the patient (such as treatment). This classification system has a series of rules so you can figure out where your product sits.

There is a greater emphasis on the performance of the IVD and its technical documentation. There needs to be scientific valid approaches to the assessment of data in areas of analytical performance. Manufacturer will need to consider statistics and sample sizes when gathering performance data of the IVD .

What should manufacturers do now to prepare?

Make sure you start planning and create a plan for existing and new products. The dates will not be moved again.

What about Brexit and UKCA?

The IVDD is currently UK law but there is a consultation ongoing to alter the law so it is more closely aligned with the IVDR. This is the same for medical devices as well. Currently CE marked products are acceptable until the middle of 2023, but expect that date to change because of NB resource issues.

 

Watch the interview on the IVDR below:

Learn more about the course: Fundamentals of the EU IVD Regulation (IVDR)

 

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