There have been a number of approvals which are set to be released imminently, so members should review the approved list which can be found at CTDA – approved-products
Over the Christmas period, most suppliers have provided the outstanding requested information and those are still in the evaluation stages. There are approximately a dozen suppliers that have been rejected, but this is due to the non-provision of data which has been requested and the CTDA team has not received any correspondence for some time, so these applications could arguably have been self-withdrawn.
Guidance for the approvals process is due to be updated, with more clarity and detail to make the provision of data easier for suppliers based on feedback from BIVDA over recent months. At present, there does not appear to be any pursuit of the laboratory validation as part of this process, but this is in review and BIVDA will keep members informed of any further information.
We hope to see some variation in the criteria which will be more appropriate to the requirements and the ability of suppliers to get the necessary data.
As evaluations are concluding, we also expect the CTDA to issue rejections for applications. At present there have been no failures. The legislation details the appeals process, but if it is for non-provision of data, suppliers will have to simply prove the information was sent in time and in the correct format for any further action to be taken by CTDA.
We expect that the protocol list will be updated and extended at the end of February on the grounds of public health requirements which was the original criterion for the list.
BIVDA pointed out that with the number of tests officially approved, that at the very least we would expect the list to be significantly smaller due to the minimised risk to the public for access to tests, although we argued that unless there was something specific that would cause a Trust or a Provider significant operational difficulty it should not exist at all. CTDA said the list had always been constructed based on this criterion but CTDA were not in a position to confirm which if any tests would be on the protocol after the deadline or whether there would be any extension at this stage due to the number of pending approvals.
Two outstanding queries were answered, the first is any supplier who used the PHE assay as a comparator cannot use this as the PHE assay is not CE marked. This went to the scientific review committee on BIVDA members’ behalf and was discussed in detail before being refused as an acceptable comparator.
The second query was a clarification in relation to MHRA registration.
CE marking is a pre-requisite for CTDA approval. Once it is CE marked and approved by CTDA then it can be registered with MHRA. Self-Test applications require a Notified Body certificate as evidence of conformity. Declarations of conformity are accepted for other applications where Notified Body review is not required.
We are continually liaising with the CTDA team, and where members have asked questions, or sought our support we will be getting back to you as soon as answers are provided.
We will maintain a respectful and positive dialogue with the CTDA and government whilst robustly driving the issues and concerns of our members through our direct channels to ensure that other policy is unaffected.
Please contact Helen for any further information.