IVDR Transitional Extension: Why full speed ahead is still the best strategy

Kirsten Van Garsse, Director AR Services and Manager IVD RA and Sara Van Wouwe, Consultant IVD - RA

Clinical

Regulatory Affairs

In Vitro Diagnostics

Monday, 08 April 2024

IVDR Transitional Extension: Why full speed ahead is still the best strategy | QbD Group

3:32

In the dynamic landscape of medical device regulations, the recent proposal by the European Commission to extend the transitional period for In Vitro Diagnostic Medical Devices (IVDs) under the IVD Regulation (EU) 2017/746 has sparked discussions and considerations across the industry. While the extension may seem like a luxury for legacy device manufacturers, it’s crucial to understand why maintaining momentum toward IVDR compliance remains crucial. Let’s explore the key reasons why moving full speed ahead is still the optimal strategy despite the transitional extensions.

1. Business Competitiveness

Innovation drives success in the medical device industry. Transitioning to IVDR compliance ensures that manufacturers stay competitive by swiftly adapting and refining their products to meet evolving market demands. With competitors already securing IVDR certification, delaying compliance efforts could result in falling behind the curve, jeopardizing market positioning and revenue opportunities.

2. Regulatory Limitations of Legacy Devices

Under the IVDR, legacy devices are effectively frozen in terms of design and intended purpose since its date of application in May 2022. This restriction locks manufacturers’ entire legacy product portfolios, presenting a clear disadvantage in an industry characterized by rapid technological advancements. Transitioning to IVDR compliance unlocks the potential for product evolution and innovation, essential for long-term business sustainability.

3. Compliance Timeframes and Notified Body Capacities

While the transitional period provides some breathing room, the complexity of IVDR compliance should not be underestimated. Manufacturers must meet specific deadlines for transferring devices to the IVDR and undergo conformity assessment, which can take up to 18 – 24 months. With the potential for Notified Body capacities to become strained as deadlines approach, spreading the workload and allocating resources wisely becomes essential to ensure timely certification.

4. Industry Preparedness and Crisis Mitigation

Taking a proactive approach to IVDR compliance mitigates the risk of facing a crisis closer to the declaration of equivalence deadlines. Waiting until the last minute to initiate compliance efforts could lead to resource shortages, bottlenecks in certification processes, and ultimately shortages of vital diagnostic tests in the market. By maintaining momentum and spreading out compliance efforts, manufacturers can contribute to industry-wide preparedness and crisis prevention.

Conclusion

While the proposed extension of the transitional period for IVDs under the IVDR may offer temporary relief, it’s clear that maintaining momentum toward compliance is essential for long-term success and competitiveness in the industry. By embracing the transition, manufacturers can unlock opportunities for innovation, ensure regulatory compliance, and safeguard their position in the market. In navigating the complexities of IVDR compliance, moving full speed ahead remains the most prudent strategy for manufacturers seeking sustainable growth and resilience in an ever-evolving regulatory landscape.

Stay ahead in life sciences

Keeping up with the fast-paced life sciences industry doesn’t have to be overwhelming.

Our newsletter delivers the latest insights, industry updates, and expert content directly to your inbox, helping you stay informed and make smarter decisions.

Subscribe to our newsletter

Discover more expert content

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Discover all