The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Yes, yes, do translate the text and see for yourself what it says :
"Lorsque le DMDIV dispose d’un marquage CE, la procédure habituelle de déclaration est disponible ici"
Links to : https://ansm.sante.fr/page/mise-sur-le-marche-des-dispositifs-medicaux-et-des-dispositifs-medicaux-de-diagnostic-in-vitro
"La mise sur le marché des dispositifs médicaux (DM) et des dispositifs médicaux de diagnostic in vitro (DMDIV) s’effectue dans un cadre réglementaire européen. Ce cadre fixe les “exigences essentielles“ de santé et de sécurité auxquelles doivent se conformer les fabricants pour garantir la sécurité et la fiabilité de leurs dispositifs mis sur le marché européen. Le marquage CE apposé par le fabricant est le garant de cette conformité.
Pour obtenir un marquage CE, le fabricant doit constituer une documentation technique présentant les preuves permettant de démontrer la qualité et de la sécurité du dispositif. En fonction de la classe de risque du dispositif, un organisme habilité indépendant (dit “notifié“) intervient dans le processus de marquage CE. Celui-ci évalue la conformité du dispositif et le système qualité du fabricant et délivre, en cas d’évaluation satisfaisante, un certificat de conformité permettant au fabricant d’apposer le marquage CE sur son dispositif. Le marquage CE a une durée de validité limitée. La pertinence de la documentation technique et l’organisation du fabricant doivent faire l’objet de nouvelles évaluations périodiques par l’organisme notifié.
Une fois mis sur le marché, le dispositif est sous la responsabilité du fabricant qui le commercialise. Celui-ci doit assurer une surveillance de ses performances et de sa sécurité, vérifier qu'aucun problème ne survient à l'utilisation pour, le cas échéant, prendre des mesures préventives ou correctives.
Les autorités sanitaires dites « compétentes » sont, en Europe, responsables de la surveillance du marché et de la désignation des organismes notifiés."
Prickymatters with your imaginary MBA, better luck.next time
Date McNumbskull. See my explanation to Gloria. Use the translation button.
Gloria, you can translate to English. That's not what it says. And there's a list of approved tests. Is GDR on it?
But Prickymatters with his MBA still don't understand the CE mark. There you have it from across the pond.
Mr Allah, may I ask, Do you have or will be buying GDR shares?
"Let's take the example of a validation process from over the pond :
https://ansm.sante.fr/dossiers-thematiques/covid-19-vos-demarches-durant-la-pandemie/covid-19-commercialisation-des-dispositifs-medicaux
"Dépistage de la COVID-19 et dispositifs médicaux non marqués CE : les fabricants doivent se déclarer auprès de l’ANSM avant mise sur le marché"
The header is self-explanatory. Only the PCR tests which have NOT been CE marked are required to undergo additional evaluation through a state laboratory. The products which have indeed received the CE mark can be directly commercialised.
Have a good shopping spree tomorrow."
Let's take the example of a validation process from over the pond :
https://ansm.sante.fr/dossiers-thematiques/covid-19-vos-demarches-durant-la-pandemie/covid-19-commercialisation-des-dispositifs-medicaux
"Dépistage de la COVID-19 et dispositifs médicaux non marqués CE : les fabricants doivent se déclarer auprès de l’ANSM avant mise sur le marché"
The header is self-explanatory. Only the PCR tests which have NOT been CE marked are required to undergo additional evaluation through a state laboratory. The products which have indeed received the CE mark can be directly commercialised.
Have a good shopping spree tomorrow.
So we can’t sell to anyone in Europe?
You know what a stupid person does though, tell you how smart they are (:
What don't you understand about 'the ECDC and the WHO are organising external validation for PCR tests '? The paper as a whole references several types of test.
Classic troll with the circular arguments. I know I'm not thick mate. I have an MBA and I worked for 15 years in R&D. I have finished the conversation with you. Wasting my time. Hopefully genuine investors now realise that we haven't got EU approval which is ongoing. I expect we will get it. I have bothered to explain this because you and others were insisting we hadn't sold in the EU despite having approval. Not true. When we get approval in the EU we can sell there.
Certainly the FDA criterion is very favourable to GDR technology.
Was just adding the wait for cheaper shares as you said you was buying tomorrow
And we are talking about the past year of his failure to sell in EU
We don't have a rapid self use test pricky which requires extra valuation. Jesus do you even know what you have invested in.
Talking to yourself again Guy?
If you wait a few days more you’ll get cheaper shares
Surprised you can see the screen with all them tears in your eyes
For Dave, who needs help with reading and comprehension.
'Therefore, it is highly recommended to carry out additional validation of the clinical performance of tests for COVID-19 by comparison with a reference method in a sufficiently large number of target population subjects before
introducing the devices into the clinical routine. Scientific peer-reviewed results for the clinical validation of commercial COVID-19 tests are highly recommended before they can be safely and reliably used for medical or public health decision making. Validation refers to confirmation that the test achieves the performance levels specified by the manufacturer.
Such studies are being done by competent authorities and reference laboratories in Member States. There are obvious benefits of sharing the results of those validations and organising centralised validation studies to make the most efficient use of resources. Fast-track clinical validation studies of rapid diagnostic tests for COVID-19 by hospital laboratories are ongoing in several EU Member States. Cooperation would also be beneficial at international level where the same tests are used in different jurisdictions. Both the WHO and FIND are
currently working on validation studies of different devices.
Scarcity of reference methods and materials poses difficulties for these validation studies, and also for the evaluation of device performance by manufacturers. The Commission’s Joint Research Centre has recently developed a positive control material for RT-PCR tests which is available to laboratories in Europe. Seroconversion panels and positive sample panels are examples of further materials that are needed. Another issue currently is the lack of publicly
available comparator data, which makes it difficult to compare the performance of devices.
External quality assessment schemes could be one way to generate such data. The ECDC and the WHO are already in process of organising an external quality
assessment scheme for RT-PCR tests.
6. Actions undertaken by Commission so far
The Commission has already taken the following steps as regards market access and performance of devices:
? Facilitating continuous exchange of information between competent authorities for invitro diagnostics in the framework of the dedicated subgroup of the Medical Device Coordination Group. This includes regulatory exchanges on device conformity, availability and reliability, maintaining an inventory of devices and sharing information on national actions, covering also national derogations issued by Member States and justifications for them.
16 Note: The WHO’s emergency use assessment and listing programme (see
https://www.who.int/diagnostics_laboratory/EUL/en/) has received 30 applications and finalised'
Guy, Dave, Dr Aim,
Have you managed to finish reading a document that is more than one page yet?
Don't bother apologising.
Everyone needs to get their head around the fact that there's no way that the EU are just going to allow a CE mark to pass for validation of tests for sale across the EU. A CE mark is a quality control certificate. Many professional firms are set up to provide a CE mark. The latest on this is that Macron is now calling for a standard approach for approved tests to fit in with the covid certification scheme. Hasn't happened yet. But it will because they want the latter to be in place by July 1st.
I am buying tomorrow.
GLA.