BIVDA held our first in person working party meeting this week at 41 Portland Place. London. On behalf of BIVDA and the Chair and Vice Chair (Richard Hames and Helen Tucker) it was a real pleasure to see members again after such a long time!
The meeting was also accessible via a virtual link for members who were unable to attend in person.
Our first speaker was Stuart Angell, Vice-Chair of our Regulatory Affairs working party, who discussed the current position relating to IVDR implementation with members. The objective for the IVDR was to make the EU regulatory system more robust and enable safer and more effective devices to be placed on market.
The top 5 significant difference of the IVDR compared to the IVDD include.
Classification – risk-based specific to the analyte, results in significant uplift of requirements for current self-declared devices.
Conformity Assessment – more devices require notified body involvement for conformity assessment, higher costs and longer lead time compared to self-declaration.
Technical Documentation – format and content more defined within Annex II with additional requirements and new post-market surveillance requirements.
Clinical Evidence – new requirements for scientific validity, analytical & clinical performance and based on ongoing state of the art assessment.
Economic Operators – Roles and responsibilities defined for importers and distributors, new role for Persons responsible for Regulatory Compliance.
Key challenges discussed are that many suppliers have not yet engaged with a notified body, and there could be up to 53% of products currently supplied that will have to be withdrawn from the market. Covid-19 has impacted IVDR budgets and resource, there is limited notified body availability resulting in a bottle neck and there is no IVDR Notified Body availability for new enquiries which is crippling SMEs with existing customers facing 12-18 month lead times minimum as a minimum. Eudamed updates are not on track and MDCG guidance documents are behind anticipated timeline.
The MHRA is consulting on UKCA with a 10-week window, this was released on Thursday 16 September. Currently UK MDR2002 retains alignment to CE marking under IVDD. UKCA remains voluntary until 01 July 2023 for IVDs and non-UK manufacturers require UK Responsible Person. Additionally, device registration with MHRA is mandatory from 01 Jan 2021 with grace periods and alignment to IVDR and MDSAP is anticipated but is not confirmed.
From a contract perspective, it is important for members to check contracts or supply agreements for terms relating to discontinuation of products, failure to supply, regulatory requirements for products, disruption of services, % of PO lines, notice periods, service remedy among others to identify the contractual requirements and actions required to minimise and prevent any serious issues at customer sites.
Some of the more serious remedies for failure to supply contracted products can include KPI compensation, reimbursement of cost for any difference in cost for alternative products and persistent failure resulting in remedial action.
It is recommended to talk to end users and talk to Primary contractors if any products fall into this area.
We also welcomed Intellicentrics to take part in a discussion about credentialing. Conversations to resolve the challenges are also on-going with the LSI Register and MIA. Our current BIVDA positioning statement can be found here.
BIVDA and Intellicentrics are working on creating a framework for collaboration to benefit members which is an important step in delivering a better information about credentialing which will allow us to work together to ensure that it is relevant and proportionate to our sector.
Intellicentrics made clear that they are impartial and do not set the requirements that members have been seeing recently with the selection of requirements always hospital set. They indicated that they are willing to work with us to develop appropriate needs for IVD members and work with hospitals to implement.
Collaboration of this kind will hopefully result in education for all parties. Hospitals can gain feedback, IntelliCentrics can understand much more of the day-to-day challenges of IVD commercial visits, and BIVDA members can understand the wider reasons behind credentialing and play a part in ensuring we are all operating with the best level of knowledge.
This collaboration framework will help us offer more value to members by sharing more information and updates and offer a reduced subscription cost with them.
There is plenty more work to do, but we aim to reduce frustrations with access into hospitals but will also reflect more highly with hospitals with BIVDA members being seen as even more in-tune with hospital needs.
Basic registration is free, and many hospitals are accepting this. To see where a full subscription is required, the interactive map below may be useful.
Minutes and Presentations will be sent in due course.