REGULATORY AFFAIRS
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.
IVDR: Blockbuster or showstopper? The definition of an IVD medical device encompasses a wide range of laboratory
• B etter ability to accommodate new technologies and scientific advances • Facilitation of global trade through
IVDR: Five challenges of the change Before we consider what you can do at this point to ensure as smooth a
developed tests, point-of-care devices,
the promotion of more convergent
transition as possible, here is a brief
instruments, reagents and kits used to
regulations
recap of some of the most notable
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
While the IVDR should ultimately be a
changes and challenges the IVDR
positive step forward for the industry,
brings:
most IVD manufacturers still have a lot
1. Extended IVD definition and scope
of work ahead of them to ensure a smooth transition and avoid IVDR becoming a ‘showstopper’ that freezes them out of EU markets.
Under IVDR, the definition of an IVD device has been clarified and now encompasses more types of devices, including relatively new technologies
European regulations for IVD devices
Timeline to the new IVD regulation
like predictive genetic tests,
into closer alignment with the more
The IVDR came into force in May 2017,
companion diagnostics, and even
rigorous requirements for other
setting the clock ticking on a five-year
medical devices, and seeks to make
transition period for manufacturers
the regulatory process more ‘robust,
selling IVD medical devices into
transparent, predictable and
European markets. As the IVDR is
sustainable’.
phased in, the current IVD Directive
Some of the intended benefits of IVDR
(IVDD 98/79/EC) will be phased out.
include: • H igher standards of quality and safety for IVD devices • M ore clearly defined definitions and regulatory scope • I mproved oversight and traceability
With no grandfathering of devices already on the market, all IVDs must
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.
While five years may seem like ample
2. New device classification system
time to make the transition, there is still much more to be done and considerable uncertainty in the process, particularly since notified
throughout the device lifecycle
bodies (NB) are going through the transition process themselves.
4
makes it clear that regulatory
be transitioned to the new regulation.
across the supply chain, and
The Blog
software. The new regulation also
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
TRENDS, NEWS, STORIES AND MUCH MORE! FROM THE EXPERTS TO YOU.
TECAN JOURNAL 1/2022
