The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
"26May2022 has been set in stone as the IVDR go live date for many years. I wouldnt bank on it occurring though as there is a proposal to delay implementation for 3 to 5 years (for current on market products certified under IVDD) as labs and manufacturers are not ready to implement the change.
For example currently around 8 percent of IVD products require review by a notified body before they csn be placed to market with the rest allowing self certification for CE marking.
Under IVDR the estimate is 80 to 90 percent of products requiring this. As a high risk medical device you can guarantee COVID tests wpuld sit in this bracket.
In summary you don't want IVDR yet as it will likely kill or greatly hamper smaller companies who aren't as regulatory experienced."
You and your informed insights....
;-)
26May2022 has been set in stone as the IVDR go live date for many years. I wouldnt bank on it occurring though as there is a proposal to delay implementation for 3 to 5 years (for current on market products certified under IVDD) as labs and manufacturers are not ready to implement the change.
For example currently around 8 percent of IVD products require review by a notified body before they csn be placed to market with the rest allowing self certification for CE marking.
Under IVDR the estimate is 80 to 90 percent of products requiring this. As a high risk medical device you can guarantee COVID tests wpuld sit in this bracket.
In summary you don't want IVDR yet as it will likely kill or greatly hamper smaller companies who aren't as regulatory experienced.
Agree, looks like it’s taken the EU a few months to get their head around the science / LFT’s
“From 26 May 2022”
Wow that’s some serious can kicking down the road.
Good post by Energyshares on Avacta BB which is relevant to EU Antigen tests / interest to this BB
Pasted /posted full post below
New EU directive looking for best tests
From 26 May 2022, the Directive will be replaced by Regulation (EU) 2017/7465. The Regulation will strengthen the requirements for the evidence on performance of the device and introduce a thorough assessment of COVID- 19 tests, including RADTs, by notified bodies.
Page 15 conclusions:
“If tests are to be used to certify recovery from infection, higher specificity tests (>98%) are preferred”
There are currently many RADTs on the EU/EEA market, which vary in their performance characteristics. Independent evaluations have shown that RADTs have variable and lower sensitivity compared to NAAT tests but have a high specificity, often comparable to NAATs. The currently available data show that RADTs sensitivity is high (and can be equivalent to NAAT) in situations when the time of sampling is up to five days after symptom onset, i.e. during the infectious period. ECDC agrees with the minimum performance criteria set by WHO (sensitivity =80% and specificity =97%) and recommends use of tests that have a higher sensitivity of =90% and minimum specificity of >98%, in line with the HSC TWG list. Some of the available tests on the market are included in the HSC list of mutually recognised tests in the EU/EEA and meet the agreed clinical performance criteria. If tests are to be used to certify recovery from infection, higher specificity tests (>98%) are preferred.
RIP PCR looks like best performing tests will replace PCR.
https://www.ecdc.europa.eu/sites/default/files/documents/Options-for-the-use-of-rapid-antigen-tests-for-COVID-19-first-update.pdf