In today’s fast-paced regulatory landscape, the need for in vitro diagnostic (IVD) developers to adapt to the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) is more urgent than ever. This blog delves into the crucial transition from the In Vitro Diagnostic Device Directive (IVDD) to the IVDR, highlighting the pressing need for developers to take action.
The Countdown to IVDR Compliance: A Race Against Deadlines
The IVDR (EU) 2017/746 has brought about significant changes in the regulatory framework for IVDs, replacing the previous IVDD 98/79/EC. With these changes come a host of new requirements, along with an expanded scope of Notified Body (NB) certification for IVDs. However, the transition to IVDR has encountered various roadblocks, slowing down the process. Several factors, including the delayed designation of NBs and the disruptive COVID-19 pandemic, have contributed to this deceleration.
To tackle the issue of sluggish transition and prevent shortages of IVDs, the amending regulation (EU) 2022/112, introduced on 25 January 2022, initiated staggered extensions of transition periods based on the classification of IVDs. Although this amending regulation has provided additional time, the first deadline for Class D devices is just around the corner, set for 26 May 2025. The statistics are concerning — as of the end of June 2023, only 1,155 applications have been received by NBs, resulting in 500 certificates issued. For Class D devices, a mere 231 applications have been submitted, with only 62 certificates issued so far.
The Call to Action: Time Is of the Essence
This press release is a resounding call to action, directed at IVD developers and all economic operators in the field. The survey conducted by the European Commission underlines the fact that the initial conformity assessment process may take anywhere from 6 to 18 months, depending on the device’s risk classification.
Given the impending Class D device deadline and the existing conformity assessment timelines, it is critical for IVDR developers to take swift steps toward transition. NBs have the capacity to process applications and complete conformity assessments on time, but only if submissions are made promptly. It has been stated by multiple NBs that Class D device certificates have taken up to 18 months; therefore, it is strongly recommended to submit applications no later than the end of 2023 to ensure that technical documentation assessments commence without delays.
NBs that are members of TEAM-NB have made a collective commitment to allocate the necessary time and resources for processing device applications. They are fully aware of the implementation dates outlined in the transitional provisions of EU 2022/112 and are prepared to act, if applications are submitted in a timely manner. This call to action is not to be taken lightly, as failing to submit applications on time can potentially lead to supply chain disruptions and hinder access to IVDs in the EU.
Recommendations: Your Path to a Successful IVDR Transition
Notified Bodies within TEAM-NB, with their extensive experience and expertise in IVDR compliance, have issued the following recommendations to IVD device manufacturers:
- Contact an NB that has been designated to assess the types of devices in your portfolio without any further delay. The scope of NBs can be found on the NANDO website, ensuring you make the right choice for your specific needs.
- Begin preparing your application immediately. Make use of the forms, tools and guidance available, ensuring you submit them on time. In addition to these resources, you can find valuable best practice guidance documents representing the collective wisdom of NBs on the TEAM-NB website.
How NAMSA Consultants Can Help: Your Bridge to Successful IVDR Transition
At NAMSA, we understand the challenges and complexities of the transition from IVDD to IVDR. Our team of expert consultants includes seasoned IVDR professionals with extensive experience in guiding IVD developers through the transition.
Our comprehensive services encompass every aspect of the IVDR transition, from initial assessment to application preparation, submission and conformity assessments. We are committed to facilitating a smooth and timely transition for your IVD devices. With NAMSA by your side, you can rest assured that your compliance needs are in capable hands.
Don’t let time slip away. The IVDR transition is not just an obligation; it’s an opportunity for growth and sustainability in the European market. Contact NAMSA today and let us be your trusted partner on the road to IVDR compliance. Your success is our mission, and your future in the IVD industry is our priority.
Also be sure to check out our expanse of complimentary IVDR resources at https://namsa.com/resources/ivdr-planning/.
Warren R. Jameson, PhD
Over 15 years experience in IVD research, development, manufacturing, regulatory affairs and quality management. Served in Research and Development as well as Quality and Regulations Manager ensuring compliance with legislation, managing quality documentation, risk assessment, risk management and audits. Expert in reviewing technical files and guiding IVD sponsors for IVDR compliance. Creating technical documentation such as Performance Evaluation Plans (PEP) and Reports (PER) for IVD devices to be used as part of technical file submissions for IVDR compliance and to carry out performance evaluation. Significant experience in gap analysis reviews of analytical performance and clinical performance data and determination of the data is to the latest guidelines for performance, acceptable to IVDR standards and advise on solutions. Clinical performance creation including review of clinical performance protocol, studies and literature to determine the needs of devices and any gaps for IVDR compliance or US submissions. Scientific Validity report creation with search and review of scientific literature for analyte link to pathological or physiological conditions as stated in the IVDR for legacy and novel devices.