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that would be good. maybe 5m priced in and if sovereign test news comes to take that to a 30m min it may mean 600m extra profit per year for a few years which on its own would put a bit of a short term thruster blast and long term burn under the Avacta sp, It would also provide a kind of validation that this is something for other governments to look at.
Cheers for that Celtics - very useful!
It's another subtle clue from our great leader (he has dropped many).
He has already told us the only way to sell tests in the UK is to sell to the UK GOV are they are giving them away for free to users.
So reference to MHRA is another clue as to what is about to unfold.. which won't come as a surprise to the well researched
A useful document regarding medical device registration from the MHRA. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/978379/Device_Registration_Reference_Guide_April_2021_Final_v1.pdf
"Within 6 working days from submission you should receive an email confirming the outcome of the application."
thanks,
Celtics.
EU Directive 98/79/EC continues to be relevant in UK as well as EU until we have a similar approval standard.
MHRA is the competent authority in the UK Each of the EU countries has a competent authority. They maintain the register of medical device and IVDs. They also designate notified bodies who approve CE marking of medical devices/IVDs when required.
The notified body will review the legal manufacturers technical documentation and also confirm that the legal manufacturer has suitable systems and procedures in line with the requirements of the directive. This is usually through 3rd party certification body vs. ISO13485.
Some medical devices/IVDs can be self declared and do not need to be approved by a notified body, on the basis that the technical documentation has been completed and that company systems and procedures meet the requirements of the directive/ISO13485.
Avacta are using BSI certification services to enable ISO13485 certification.
For professional use IVD, they do not need a notified body, but can self declare.
For self test, they need a notified body in UK and EU and I would assume that they will be using BSI UK notified body (0086) and BSI NL notified body (2797) in UK and Netherland respectively.
GLALTH
The notified body is the likes of BSI - Not the MHRA. This has already happened.
That could relate to home use perhaps ?
This is the wording from the EU directive (So for the purposes of Europe, the conformity assessment is done by the manufacturer i.e. Mologic, so the fact MHRA have had to get involved is interesting)
"Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group in vitro diagnostic medical devices into two main product classes; whereas, since the large majoritybof such devices do not constitute a direct risk to patients and are used by competently trained professionals, and the results obtained can often be confirmed by other means, the conformity assessment procedures can be carried out, as a general rule, under the sole responsibility of the manufacturer; whereas, taking account of existing national regulations and of notifications received following the procedure laid down in Directive 98/34/EC, the intervention of notified bodies is needed only for defined devices, the correct performance of which is essential to medical practice and the failure of which can cause a serious risk to health;"
P3 Section 22 of the below:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079&from=EN
and the relevant part of today's RNS:
Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the Declaration of Conformity for CE mark of its AffiDX® SARS-CoV-2 antigen rapid test for professional use has been submitted to the Medicines and Healthcare products Regulatory Agency ("MHRA") through the Group's partner Mologic Limited.
Onwards Avacta.
Trust this helps:
An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law.19 Feb 2021
Onwards Avacta
The CE mark is self certified by mologic.
Mhra are approving the test for something else perhaps...
Not feeling smart so what am I missing
If MHRA cant do the approval for Europe- who does?
Thanks
Bump
https://www.gov.uk/guidance/ce-marking
Notice the last sentence - MHRA cant do the approval for Europe, which suggests UK sales are imminent. I assume that is to make it easy for Medusa to sell to UK and Europe from day 1.
3. Identify whether an independent conformity assessment is required from a Notified Body
Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. This is not obligatory for all products, so it is important to check whether the involvement of a Notified Body is required. These bodies are authorised by national authorities and officially ‘notified’ to the European Commission and listed on the NANDO (New Approach Notified and Designated Organisations) database.
UK conformity assessment bodies can no longer carry out mandatory conformity assessment for products being placed on the EU market.