Member Info for RegulatorUK

For medical devices (which includes IVDs) CE marking enables professional use. The route to self use will depend on which Annex of the regulations they fall under. The simple position is:

- all in-vitro devices (IVD) other than devices for self-testing or devices appearing in Annex II, the manufacturer can CE mark when they meet the prescribed conformity requirements;
- IVDs appearing in Annex II list A and Annex II list B are either subject to either audit or examination by the notified body before they are CE marked (the exact nature of what is required is laid out in Annexes III-VII);
- all self-testing IVDs (excluding those which appear in Annex II) requires specific examination by and approval from the notified body.

There are three notified bodies in the UK for medical devices, apart from the MHRA. These are BSI Healthcare, SGS UK Limited, and UL International (UK) Ltd. These three can only deal with Annex II list A & B self-test devices (as well as providing support/testing for non-self test devices as well).

All non-Annex II self-test IVD approval goes through MHRA. This will include all Covid IVD tests.

MHRA approval for self-use *does not* mean that they can automatically be sold directly to members of the public. This may be permitted in the case of antibody tests (albeit some time in the medium term rather than the short term) but it is very unlikely to happen with antigen LFTs, due to Covid being a notifiable disease.

"Regulator- so now your saying we have no had a single order."

That's not what I'm saying. The fact you have to resort to a straw man argument says a lot...

"Punter- I’m not sure you have realised but our test is in the market."

That depends on how you define "in the market". At present, the only customer for the UK-RTC test is HM Government - and that customer has complete control over the access to that test. Government consent is required for that test to be sold to any other party, whether domestic or overseas... and CK was very careful in the wording he used in the presentation around whether or not that consent had been given.

I think it's worth remembering that, for the UK-RTC test, the orders do not go to ODX but Abingdon and (as per the recent presentation) ODX will not be RNSing every UK-RTC order.

"Well you'll definitely be living the LOR once this one bolts properly. I'm thinking 40p by Xmas and £4 April once the sales figures/revenue pours in"

£4 ?!?! That's just daft ramping...

There's no need to be stupidly rampy about this, as this is a good long term hold.

"RegulatorUK, some of us have day jobs and are not glued to the plethora of idiotic messages , childish innuendos etc so give someone a break if they repeat a message!"

So do most of us - you're nothing special.

"At least it was useful and informative unlike the tribes of idiots we have on here."

At 14 posts you manage to make it to the green bin. ...

"Regulator do you have a target SP?"

No. I'm looking to hold these medium to long term.

I do hope so, as my average price is 0.89p... :-)

That's already been discussed several times Vascular...

"To fly kits from China! would you trust a Chinese kit?"

Why not? They're already in use and have been for some time in the UK. This order was to secure supply until the UK-developed antigen tests could be validated and delivered.

"I’ve never filtered anyone but I think this may be the first. Initially it was quite funny but now I feel bad for laughing."

My filter list is ever expanding - but it does make these boards more readable and coherent...

... would be nice and timely.

I presume that the "very early talks with Avacta" were something along the lines of

"Oh, you're going to have an antigen test, are you - that's nice. Where exactly are you in the process? ... Ah - how about we shelve this discussion until you actually have a test that's ready for production."

;-)

"Long term holders are sitting pretty, it's everyone else that's not enjoying the slide too much"

I've repeatedly said this isn't a stock for the day-trading 10%ers... this is a stock for longterm holders who understand the value in the ODX portfolio.

I think there will be a bit of market weakness generally, which will cause a few ups and downs, but that ODX will inexorably creep ever upwards.

LTHs might just want to switch off and come back next week...

The reality is that it’s somewhat irrelevant if the LFT is antigen or antibody - the same production processes effectively apply to both, so they’ll potentially be able to switch staff from one to the other.

@Vascular - that was posted two months ago and really isn’t relevant to what is being discussed.

“ How long have they been waiting for mhra seems scandalous ...”

And just how long have they been waiting?

I though we were getting a higher amount on the Visitect triple antibody, as the sale is general rather restricted to LMI countries?

I should note that there are three notified bodies in the UK for medical devices, apart from the MHRA. These are BSI Healthcare, SGS UK Limited, and UL International (UK) Ltd. These three can only deal with Annex II list A & B self-test devices (as well as providing support/testing for non-self test devices as well).

All non-Annex II self-test IVD approval goes through MHRA.