Low risk IVD study in the UK, do I need MHRA approval?

[Des_M]

Hey there.

I am part of a small start up based in the UK (Scotland), we are developing a non-invasive IVD. We are Class A so we are going to self certify as this is a very low risk IVD. We are partnering up with a local hospital for a performance study and I'm really keen to know if this requires any regulatory submission to the MHRA.

We are conducting this as per the IVDR and we are also operating under a full QMS as the data generated from this study will be (in small part) used to support future regulatory submissions down the line. As per the IVDR we will obtain ethics approval as well of completing all other documentation however I don't see any requirements for MHRA submission. Please help and advise.

Thank you very much for your help in advice.

Des M

 

[twanmul]

Hi there,

The type of Clinical Performance Study is independent of the classification of the device (unlike the Conformity Assessment route which is dependent on the device classification) to a large extent.
The main factors are within Article 58 and are as such:

Any performance study:
(a) In which surgically invasive sample-taking is done only for the purpose of the performance study;
(b) that is an interventional clinical performance study as defined in point (46) of Article 2 (‘interventional clinical performance study’ means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment); or
(c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,

If one of the above applies, you're not only bound by Articles 57 and 58 but also Annexes XIII and XIV which will require regulatory approval. As to how that is now done in the post-brexit world under the IVDR (now that the MHRA are no longer an EU member state competent authority) is completely unclear to me, so if you do require regulatory approval, then please feed back how that works!