Bob Tilling, VP global sales at Kallik, discusses the compliance challenges facing in vitro diagnostic device manufacturers.
The EU’s In Vitro Diagnostic Regulation is set to be implemented in May 2022, with further UDI implementation deadlines set for critical in vitro devices used to detect life-threatening diseases (Class D) in 2023, 2025 (Class B and C) and 2027 (Class A). IVDR is set to reshape product classifications, quality management and how existing products already sold within the EU are managed in a bid to improve device safety, effectiveness and traceability, with over 80% of devices previously not requiring certification under IVDD (In Vitro Diagnostic Directive) now requiring IVDR certification.
Manufacturers must ensure timely compliance with every aspect of IVDR to avoid financial impact, operational disruption and permanent damage to brand reputation in the event of consumer harm caused by device quality or traceability issues.
Act early
Manufacturers that have already completed an MDR compliance project for May 2021 may be tempted to sit and delay IVDR efforts. But the scale of these compliance tasks and the wide-ranging impact regulation has on operations and the supply chain is often underestimated, and only uncovered during the initial assessment stages of a compliance project.
There are many nuances to labelling under IVDR, including major differences between medical and in vitro device artwork, and layout design changes to accommodate increased traceability information such as Unique Device Identifiers. The sheer volume of work means manufacturers that embrace IVDR compliance as an early business priority and plan accordingly will stand a greater chance of succeeding without incurring major expense or affecting day-to-day operations.
A key takeaway from successful Kallik projects helping manufacturers comply with MDR was the value of adopting a best practice approach to successfully hit deadlines. Companies that have chosen to ‘go it alone’ and push ahead with compliance efforts using manual processes and legacy in-house systems have often struggled as the scale and complexity of the task becomes apparent.
There are four core aspects for success when establishing an IVDR compliance project:
1. Don’t be caught out by project scale and complexity
Businesses should look to identify the scale of their compliance task as early as possible, determining exactly how many devices and associated labels and artworks exist across their global operations and supply chain. Kallik’s work on MDR compliance projects for medical device manufacturers identified affected assets numbering in the low thousands to over 150,000 – so the volume of work must not be underestimated.
Siloed data in legacy departmental systems, disconnected regional offices and even new product lines introduced by mergers and acquisitions can all significantly expand the scope and timeframe of the project once identified.
Product translations and global supply chain nuances are another common surprise when assessing the project complexity. Internationally focussed businesses will need to amend each label and packaging asset in various languages, significantly increasing the scale of work.
2. Remove the bottlenecks
Identifying every silo containing affected assets within a manufacturer’s global business footprint is the first step to compliance, but businesses should also look to consolidate these assets into a single central source before actioning changes.
Business leaders struggling with disconnected legacy systems should consider adopting an end-to-end label and artwork management solution to avoid these pitfalls. These solutions typically provide a centralised asset library to consolidate artwork, logos, phrases and other critical product data. This ‘single source of truth’ significantly eases the monitoring, editing and management burdens, helping businesses focus solely on dedicated compliance work through label editing.
3. Consolidation is key when amending assets
Once manufacturers have consolidated existing assets and standardised associated data, attention can turn to identifying and actioning specific changes that must be made to each label and artwork to achieve compliance. These can range from label sizing and placement, to warning symbol positioning and UDI inclusion – with the ever-present threat of further changes to accommodate translations and country-specific regulatory requirements.
This is another situation where a centralised label and artwork management solution can add value to the process.
4. Automation and cloud-based technology can ease the burden
One key takeaway from initial MDR compliance projects is the sheer inefficiency of many ‘traditional’ methods and manual work to update assets. As the scale of these compliance tasks increase and new regulations are announced, the processes become unacceptably slow, expensive and inaccurate – with the ever-present risk of introducing human error.
Introducing a cloud-based, centralised solution that leverages automation will eliminate much of the uncertainty caused by manual processes. The result is an efficient operation, following best-practice procedures, providing a certain outcome. Such solutions harness rules-based automation to eliminate the need to manually search for, update and republish assets to ensure compliance, and deliver significant cost and capacity savings that scale over time.
IVDR today, UKCA tomorrow?
While IVDR marks a major change to the way IVDD manufacturers operate, it is not the end of the road for industry regulation. Further changes such as UKCA markings for medical devices sold into the UK market are also in the pipeline, and further national and regional regulations are highly likely to follow, trigged by developments such as Brexit. This represents a perfect opportunity for manufacturers to establish a strong, future-proof digital foundation to deal with future industry challenges and enhance wider business processes.
