The legislation The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 came into effect on 1 September 2021 with the deadline for submissions by suppliers being the 31 August 2021. Tests would have needed to be approved by 31 October 2021 or withdrawn from the market.
On the 20 October, suppliers were written to and informed that due to issues with evidence required to approve tests under this legislation; in order to protect public health by ensuring availability of tests, the Secretary of State published a protocol listing certain tests that have both passed a public sector validation, and have a pending application awaiting validation, to remain on the market up to 28 February 2022 or until their validation application is determined.
This temporary list has caused significant confusion and many suppliers have not been included on this list even following assurance that missing information would not affect their status in previous communications. BIVDA and ABHI have been working directly with DHSC and CDTA to determine the status and details surrounding the list.
BIVDA and ABHI held a joint webinar on Thursday 28th October which was comprehensive, and more members are up to speed, but some confusion remains.
Outstanding issues include in particular the definition for products that have already been placed on the market by the manufacturer (or in some cases the UK distributor) before the 31 October 2021 deadline. The concern is that if after 31st October they pass on product that they consider to already be in the supply chain or in a warehouse then they might not be in full compliance.
It appeared from the legislation and previous statements that Manufacturers or RP’s (including Distributors in the role of RP) are the start of the supply chain and therefore will need to remove products from the market if they are not exempt or if they don’t have NHS contracts in place from prior to 28th July 2021. Distributors who were part of the supply chain, providing they have complied with any importer requirements in the regulations were thought to able to continue to supply until stock is exhausted but may not receive further stocks for onward distribution. A Letter came out to suppliers on Friday stating that this is not the case and no shipments can be made. We are seeking further clarification.
The timescales for response are unacceptable with an average response time of 5 days. However, several members have provided information some weeks ago (one as early as September) and only recently received a request for more information in the last few days. They reasonably expected that without a response to the additional information they had no further issues. The consequence is that they will now have to stop placing product on the market at very short notice and it may be several weeks before they can place product on the market again. For smaller suppliers in particular, this will have a significant impact on their business. A response and resolution has been requested.
For information already held by TVG, there is not a clear process for transferring data to CTDA, this internal process may have delayed getting much needed data to CDTA to support an application. Clarity direct to members has been requested.
We also sought a response to our request for an update to the temporary protocol list including resolving any anomalies resolved following our communications with them.
CDTA informed us that the further communications are currently being finalised and will be sent shortly to all applicants.
Where further questions arise you should continue to raise them to either CTDA@dhsc.gov.uk or email@example.com both of which are the best route to get an update on application progress and ensure communications are logged in case thee are required to be referred to in any future correspondence or supplier action.
In order to better understand the impact of the CTDA regulations on the industry, ABHI and BIVDA are running an urgent survey.
Please can you complete the survey found here as soon as possible, but no later than COB 1 November 2021. All data will be collated and anonymised before being shared outside of ABHI and BIVDA.
If you have any questions please contact firstname.lastname@example.org