Embracing the IVDR transition

What is the IVDR?

IVDR stands for In-vitro Diagnostic Regulation and, with its amendments, is the new set of regulations governing diagnostic devices which came into force as of May 2017, with a stepwise transition period ending in May of 2028. These new regulations represent an update to the In-vitro Diagnostics Directive which is now over 20 years old and doesn’t encompass many of the innovations that have happened in the diagnostics field. The intention of the new IVDR is to provide state-of-the-art regulations for a rapidly developing industry. IVDR will provide comprehensive coverage of technologies that were introduced after IVDD such as Next generation sequencing and point of care diagnostics. It will also demand or require an increase in quality standards, product safety, and regulatory transparency with the alignment of notified bodies around these new regulations.

Watch our webinar with the European Pharmaceutical Review (EPR) on demand!

To learn more about the IVDR and concrete steps for how to make your products compliant, join us in a live webinar hosted by EPR. In this webinar you will hear about the latest news about IVDR as well as examples for how to navigate the regulatory landscape.

Watch now

Mind the gap – how to navigate the IVDD-IVDR transition

The new IVDR requires that around 80% of devices need oversight from a notified body meaning that most companies will have to revaluate their product portfolio and assess which products will require up- classification according to IVDR rules. Not only are more devices now covered by the regulation, but new elements of their production and distribution must also be closely monitored and regulated. IVDR has specific sections for the control of supply chains as well as the life cycle of diagnostic devices.

Read more here

The supply chain for diagnostic devices will come under more regulatory scrutiny than ever before. Every piece, component and reagent must be documented and assessed to make sure it adheres to the new standards. While this is clearly an extra resource burden on companies, it is also a great opportunity to improve relationships with suppliers and to guarantee higher quality products. As an OEM provider, we are going the extra mile to take this regulatory burden away from our customers.

Read more here

Achieving IVDR certification that meets EU regulation in 2022

The IVDR will still apply in May 2022 for new IVDs and Class A non-sterile devices, but allows for a more gradual implementation – between 2025 and 2028 – for devices in other classes and in-house assays, provided that, from the date of application of this Regulation, those devices continue to comply with the IVD Directive, and there are no significant changes in the design and intended purpose of those devices. This article discusses the important changes, challenges, and benefits of IVDR, as well as an industry insight into how to work together to ensure IVD devices are, and continue to be, compliant.

Read more here

Is your business IVDR ready?

There is a lot of work to be done before IVDR completes transition in 2022. However, the burden is shared by everyone, notified bodies, regulators and companies are all working together to be ready. Now is the time to foster relationships notified bodies on order to find the smoothest path through the regulations. The main challenges for businesses now are to identify gaps, streamline process and establish efficiencies both internally but also for the external review process to help avoid bottlenecks.

Watch now: Is your business IVDR-ready, or are there treacherous gaps in your strategy?

Transforming challenges into opportunities

Despite the significant amount of resources that are required to reach and maintain compliance, there are many opportunities in the IVDR. To start, when you consider that authorities and companies around the globe are now working together to deliver what the patient needs according to a single rule book, you can begin to see the real power of IVDR. In the past, under IVDD, countries were able to interpret the rules for their local markets leading to discrepancies and confusions. This also made selling into different markets challenging. Now with IDVR, everyone is subject to the exact same rules when placing IVDs on the EU market allowing greater consistency and higher quality.

It is also important to note that we are all in this together. Regulators, notified bodies, big and small companies alike are all facing the same challenge. This is a great opportunity to reach out and forge new relationships and partnerships that can benefit everyone going forward. Our customers will also be subject to the new IVDR and will likely be worried about achieving compliance. Now is the time to show leadership and demonstrate a clear path to compliance which will ultimately increase trust in the whole market.

Watch now: Do you transform the challenges into opportunities?

Tecan is IVDR-ready and we are here for you!

IVDR claims to promote high levels of safety and quality while supporting innovation and this is something that we 100% support. We are embracing the new regulations and bringing all of our processes and documentation in line. We understand that broad regulations like this can make it challenging to foster innovation. On the surface, many sources of innovation such as laboratory test will vanish under the new IVDR and smaller companies may struggle under the regulatory burden. This is something that we cannot allow to happen and Tecan is here to empower innovation and to provide real support to the diagnostics community.

Watch now: We are IVDR-Ready!

Listen! New podcast episode discussing IVDR

Join our VP of Global Regulatory Affairs, Laura Nea, as she discusses how the new in-vitro diagnostics regulations are affecting the life sciences landscape and what she has learned while spearheading Tecan’s efforts to prepare for the new regulations.

Listen now!

Request more information on Tecan IVDR compliant products

Simply fill out the form below. We’ll help you resolve your issues quickly and easily.