There’s much uncertainty and concern about the new IVD Regulation in Europe. The new regulations began this past European holiday weekend, and begin a lengthy transition to implementation. If you are wondering how this may work out, look Down Under, where at the end of June, Australia will complete its transition to new IVD Regulations (IVDR).
And the Australian Model is very similar to what’s planned for Europe.
Re-classifications bring most IVDs into premarket review
Australia’s Therapeutic Goods Administration (TGA), like Canada, uses a Global Harmonization Task Force (GHTF) classification model for IVDs. Essentially it’s a four tier system where the class is determined by the risk associated with the test outcome.
|Class||Public Risk||Personal Risk||Examples|
|4||High||Tests used to screen blood supply for HIV, Hepatitis|
|3||Moderate||High||Human genetic tests, blood typing, Cancer diagnostics|
|2||Low||Moderate||Urine dipsticks, liver enzymes, folate, sodium, potassium
Non assay specific QC Materials
(Class 2 is the Default class)
|1||No||Low||Reagents, Instruments, laboratory equipment, microbiological culture media, specimen receptacles|
The important thing to understand here is that under this scheme, unless otherwise defined, IVDs default to Class 2, and that means that a Conformity Assessment is required.
So with the introduction of the GHTF classification, Australia went from a regulatory scheme in which only a few high risk IVDs required TGA assessment to one where almost all IVDs are subject to TGA review.
And the same is about to happen in Europe. The old IVD Directive (IVDD) uses a List A/B scheme which captures only a small number of high risk IVDs. Now under the IVDR, most IVDs will require a Notified Body review.
Expect a shakeout…
What does this mean for the industry? Well the Australia experience was one of a considerable shakeout. Manufacturers reviewed their catalogs and many low volume test kits were pulled from the market as the regulatory cost couldn’t be justified. Some smaller players departed the field altogether.
…and struggles for regulators too.
In Australia there was confusion and slowness to adjust, both by manufacturers and the regulator. The transitional deadlines were extended as industry struggled to prepare the necessary Technical Files and make their submissions,. Submissions were held to the last minute and TGA could’t cope with the peak in workload, leading to slow reviews considerable backlogs and the inevitable extensions of deadlines.
In Australia there is also a notification scheme for Laboratory Developed Tests (LDTs), where Labs are required to notify TGA of the tests they conduct. Using this database, TGA compares notes with NATA, Australia’s national laboratory accreditation body – to ensure that tests being supplied have been appropriately validated and accredited. The highest risk, class 4 IVDs require TGA approval even if they are supplied as an LDT. The adjustment to having to file TGA submissions has been difficult for many laboratories and again TGA extended the transitional deadline by another year.
And more widely – what about clinical evidence?
Regulations are becoming stricter everywhere and in particular regulators are stepping up requirements for clinical evidence. The impact of the international trend towards stricter clinical evidence requirements remains to be seen, but be prepared for regulators to expect more clinical data, especially for higher risk IVDs and things like companion diagnostics where there’s a parallel medicines review involved.
So – it’s very early days in Europe, but given that the Notified Bodies are dealing with both a medical device and IVD transition at the same time, that there will be fewer notified bodies to do the work, and for most of the industry, dealing with conformity assessment will be a painful novelty, don’t expect things to go to plan.
Re-harmonization for TGA?
And down in Australia, this is being watched with interest. For medical devices, Australia accepts CE certificates in lieu of direct TGA assessment. This is rare for IVDs as the current IVD Directive is so different to the Australian regulations. Expect to see TGA seeking to leverage CE far more under the IVDR. (By the way, TGA also accepts Canadian licenses as evidence for registration of some IVDs – given the similarities of the way Canada uses the GHTF system).
For European IVD suppliers, prepare early, look at your catalogues and decide which IVDs you intend to transition to the new regulation, and get in the queue soon, it’s time to start talking to some Notified Bodies.
Link: Click here for other articles on IVDs in China, USA and more.
Are you in transition or bringing a new diagnostic to market? We support IVD strategy, regulatory compliance and reimbursement in international markets. With offices in Australia and Beijing we offer specialty support across the Asia Pacific and beyond. Talk to us about IVD requirements and market access in the US (including 510(k) de novo submissions), Europe, China, Japan and the Asia Pacific. Contact Us for a free no obligation discussion of your needs. Email firstname.lastname@example.org or call +61 2 9906 2984