The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
It is specific to antibody tests
Novo Holdings are the investment arm of Novo Nordisk.
@effinhope - they do not to buy an Lft manufacturer, they need to show that they have management and control of all their subcontractors - designers, manufacturers and distributors.
Abcam and Bioserve could offer teagents without ISO13485 because they are just reagents and could be used for research use and it is upto the user to ensure that they have suitable controls if they wanted to use them in medical devices.
They have a commercialisation agreement with Mologic which was meant to be temporary until they got their own (suitable) certification. This will have to continue until they sort out the scope
I have been emailing various people and some bounced - Alistairs, Mary etc - but some did not bounce including David Wilson, Matt Johnson and FTI. nobody is answering the phone
It is not a problem because we have Mologic to fall back on, but it is concerning that they have not understood the implications and importance of the scope.
Avacta news - is much clearer what their ISO cert actually means
CautiousOptomist - I also cannot square it with the wording of the RNS. I am concerned that they do not understand the importance of the scope wording. When they apply for self test approval (not self certified) through a notified body - they have to provide product technical documentation and at the least details of the their certification to show that they have been audited for the specific legal obligations of a medical device manufacturer. If they send this cert off it shows they can make affffimers for other people to use in their medical devices, but nothing about their ability to design, make and place on the market their own medical devices.
If Avacta want to place the products on the market themselves, their scope must cover design and manufacture, otherwise they are tied to Mologic who will have to continue to be the named manufacturer on all their technical information/IFUs etc
No we are not - the legal manufacture scope should clearly state that they are responsible for the design and development of the products including the management and control of the subcontracted activities. I have tried emailing AS etc but email has bounced. I have emailed fti, but if anyone has any other access - let me know
From a regulatory point of view Mologic will continue to be our legal manufacturer. I thought that this was only going to be short term until Avacta got their certification.
This certification scope does not describe a legal manufacturer role.
Not sure if this has been noted but Avacta certificate details is now visible on BSI websire/ client directory.
Good news - a little
Scope is
The manufacture and distribution of Affimer reagents for use by third parties for Lateral Flow, ELISA and immunodiagnostic in-vitro diagnostic devices.
Bad news, from a regulatory point of view - this would not support Ce marking of the LFT. A suitable scope for a legal manufacturer would be - Design and manufacture of Lateral Flow Devices - then add in the affimer scope to support the other activities
Not sure why Medusa 19 is not visibly doing more to distribute the professional test currently CE marked. I believe this was covered in the original RNS, and In particular the Medusa 19 website quotes
‘This agreement provides Medusa 19 with exclusive distribution rights to consumers and non-exclusive distribution rights to businesses’
A fluorescent antigen test would need some sort of reader
The application for CE marking for self test is through Notified Bodies - probably BSI UK and BSI Netherlands for Uk and EU respectively. They will have to review technical documentation particularly the additional lay person trials.
Due to changes in the directives Notified Bodies are booked up mon5s in advance so I hope this has been replanned.
Updates today to show Mologic Sars Cov 2 test. - it is us.
Nice new website - good info on the LFT.
No update at Medusa yet.
Nothing is submitted to the MHRA for registration - except to fill in the form, allocate a product type/code to allow the product to be registered. MHRA does not check anything, just make sure you have paid. I believe the form can also be filled in on line. MHRA confirms that the product is on the database, and this confirmation allows the product to be marketed.
It should not take long - and I assume should already have happened. Mologic, since they are being named as the manufacturer, should have had confirmation that the product is registered by now, but nobody is telling us.
Registration is a formality, and MHRA just confirms in writing that the product has been registered.
Branded by Siemens, made in China
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