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7 Mind the gap: How to navigate the IVDD-IVDR transition
Mind the gap: How to navigate the IVDD-IVDR transition
Is your business IVDR-ready, or are there treacherous gaps in your strategy? We are now approaching the end of the five-year transition to the In Vitro Diagnostic Regulation (IVDR) 2017/746 – a major regulatory overhaul that calls for reclassification and recertification of all in vitro diagnostic (IVD) devices registered in the European Union. With its expanded scope and more stringent requirements, IVDR impacts the entire supply chain, and there’s no time to lose. We can help you take stock of the situation, with a special focus on how to prepare when it comes to managing OEM relationships and new partnerships.
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IVDR: Blockbuster or showstopper?
The definition of an IVD medical device encompasses a wide range of laboratory developed tests, point-of-care devices, instruments, reagents and kits used to analyze human samples and guide clinical decision-making. Until now, most governments have taken a relatively lenient stance on the regulation of IVD devices compared to pharmaceutical drugs and medical devices that come into direct contact with patients. IVDR 2017/746 brings European regulations for IVD devices into closer alignment with the more rigorous requirements for other medical devices, and seeks to make the regulatory process more ‘robust, transparent, predictable and sustainable’. Some of the intended benefits of IVDR include: • Higher standards of quality and safety for IVD devices • More clearly defined definitions and regulatory scope • Improved oversight and traceability across the supply chain, and throughout the device lifecycle • Better ability to accommodate new technologies and scientific advances • Facilitation of global trade through the promotion of more convergent regulations While the IVDR should ultimately be a positive step forward for the industry, most IVD manufacturers still have a lot of work ahead of them to ensure a smooth transition and avoid IVDR becoming a ‘showstopper’ that freezes them out of EU markets.
Timeline to the new IVD regulation
The IVDR came into force in May 2017, setting the clock ticking on a five-year transition period for manufacturers selling IVD medical devices into European markets. As the IVDR is phased in, the current IVD Directive (IVDD 98/79/EC) will be phased out. With no grandfathering of devices already on the market, all IVDs must be transitioned to the new regulation. While five years may seem like ample time to make the transition, there is still much more to be done and considerable uncertainty in the process, particularly since notified bodies (NB) are going through the transition process themselves.
IVDR: Five challenges of the change
Before we consider what you can do at this point to ensure as smooth a transition as possible, here is a brief recap of some of the most notable changes and challenges the IVDR brings:
1. Extended IVD definition and scope
Under IVDR, the definition of an IVD device has been clarified and now encompasses more types of devices, including relatively new technologies like predictive genetic tests, companion diagnostics, and even software. The new regulation also makes it clear that regulatory oversight extends to devices such as home-use genetic tests that are made available to EU citizens through ‘distance sales’ (eg. over the internet) by companies based outside the EU – even if the tests themselves are carried out in non-EU countries.
2. New device classification system
One of the most dramatic changes introduced by the IVDR is the replacement of the current list-based classification system with a clear set of rules for assigning each device to one of four risk categories, ranging from
lowest risk (Class A) to the highest (Class D). Under the IVDD classification system, NB oversight was only required for products expressly listed in Annex II of the directive (about 20 percent); the vast majority of IVD devices could ‘self-certify’ without any need for NB involvement. The new regulation turns this ratio on its head, with about 80 percent of devices expected to fall into risk classes B, C or D – all of which require some level of NB oversight. Clearly, this greatly increases the regulatory burden for IVD manufacturers and their NBs.
3. Likely NB bottlenecks
With tighter regulations and more IVDs requiring oversight, the workload for NBs will rise sharply. At the same time, the number of available NBs is shrinking. When IVDR-designated NBs do come online, they will likely prioritize working with companies who have already established a relationship with them in advance, and have all their technical documentation in order.
4. Lifecycle approach
Compared to IVDD, IVDR takes a more holistic approach that spans the entire
product lifecycle, with more comprehensive measures to encourage continuous evaluation both pre- and post-launch. IVDR retains all existing IVDD requirements and adds new ones, including: • Requirements for manufacturers to establish and demonstrate an effective quality management system (QMS) • More stringent requirements for clinical evidence demonstrating conformity • New requirements for post-market performance monitoring and reporting • Introduction of unique device identifiers (UDIs) for improved traceability throughout the device lifecycle
5. Greater supply chain oversight and device traceability
The new regulations have been extended to cover the entire supply chain, adding additional responsibilities for manufacturers as well as other economic operators – importers, distributors and authorized representatives. Each link in the supply chain has the responsibility to check the previous link, and legal manufacturers must appoint a Person Responsible for Regulatory Compliance (PRRC) to ensure IVDR compliance across the chain. IVDR also gives NBs discretionary authority to audit suppliers and subcontractors if needed.
Keep calm, but don’t just ‘carry on’
As we approach the IVDD-IVDR transition, it is important to sanitycheck your progress and close any gaps in your transition strategy. Here are a few important items for your checklist:
Infrastructure: Is your current business model working for you when it comes to executing your transition plan? Are C-suite leaders – including CFOs and COOs – appropriately engaged, and is there a dedicated team empowered to drive the strategy forward? Reclassification: Have all IVD products in your pipeline and on the market been classified according to the new rules? Has a tracker been set up to indicate the certification strategy (renew IVDD certificate or pursue IVDR certification) and NB submission timeline for each device?
Portfolio review: Have cost-benefit and ROI studies been carried out? Does it make sense to rationalize your portfolio, or make adjustments to the product pipeline? Does your strategy include exploration of non-EU markets, and collaborations outside the IVD medical device industry? NB alignment: Have reclassified products been mapped against NB requirements, and suitable NBs identified? Have you reached out to NBs to enquire whether they have applied for IVDR designation? Can they send you guidelines for their application and audit process? Gap analysis: Assess technical documentation, clinical evidence, labeling and packaging, QMS, postmarket surveillance and reporting. Have available technical and clinical data been reviewed against conformance requirements? Have plans been established to acquire outstanding support data? QMS: Have you reviewed the current QMS against the new regulations? Has your QMS been updated accordingly? Has a PRRC been appointed and appropriately trained to ensure compliance across the supply chain? Transition budget: What is the burn rate to date, and does it match with projected spend to the end of the transition period? Quality contracts: Have quality contracts with existing suppliers, contract manufacturers and other economic operators been reviewed and updated as needed, with provisions to facilitate IVDR compliance?
What about outsourcing and OEM partnerships?
In this shifting regulatory landscape, OEM partnerships can be a source of great experience and guidance, or they can become your worst nightmare. In light of the extended scope of regulatory oversight that IVDR brings, it is more important than ever to partner with companies you trust, to help you design and develop high quality compliant IVD devices, supply you with the technical expertise and data you need for product certification, and ensure compliance can be maintained throughout the device lifecycle. And of course, those partners must have a QMS that is compliant with IVDR requirements.
