IVDR 3rd Anniversary. Did you take your foot off the gas? Time to accelerate!

On 26 May 2025 we are celebrating the 3rd anniversary of the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices). In addition, there are three important due dates that IVD manufacturers must consider to continue marketing their legacy IVDs on the European market:

• All IVD manufacturers must now have an IVDR-compliant Quality management system (QMS), including a system for Post market Surveillance (PMS).
• Manufacturers of IVD devices having a CE certificate under the IVDD, must have lodged a formal application for the IVDR transition with an IVDR Notified Body. The manufacturer and the Notified Body must agree on the extension of the CE-certificate.
• Manufacturers of IVD devices that were self-declared under the IVDD and are classified as class D under the IVDR, must have lodged a formal application with an IVDR Notified Body for their devices. The Notified Body shall review the applications before 26 September 2025.

For IVDR class C, class B and class A/sterile legacy devices, similar due dates will apply in 2026 and 2027 as illustrated in the figure below.

Once the transition deadline has passed, specific IVD class legacy devices that will not make the transition to the IVDR can only be placed onto the EU market under the sell-off provision. During the entire transition time, all legacy devices shall continue to meet the IVDD requirements and must not present an unacceptable health or safety risk. No significant changes can be made to the device or its intended purpose.

State of the play – the clock is still ticking …

In May 2022, we described the transition from the much lighter IVDD (Directive 98/79/EC on in vitro diagnostic medical devices) as a major cultural shift for the IVD industry. Three years later, the IVDR cannot be called “new” anymore. But even with a second amendment to extend the transition times for IVDD legacy devices and prevent shortages in IVD devices, many manufacturers are still facing challenges for the timely transition of their product portfolios to the IVDR.

With a total of 15 Notified Bodies designated for the IVDR and Notified Bodies indicating that they have capacity for review of Technical Files and for QMS certification now, manufacturers should plan and prioritize the application for the IVDR transition already before the transition deadlines.

While the European Commission is trying to find ways to ease the regulatory burden for innovative devices with a focus on SMEs, manufacturers still need to comply and should not expect another extension of the implementation deadlines.

Notified Bodies currently have availability for review of new applications within a reasonable time frame but expect a rush of last-minute applications just before the end of the transition periods for class C (26 May 2026) and class B (26 May 2027). Keep in mind that as part of the formal application process you will be required to share information on your company, devices and QMS system including the intended purpose and classification of each device and the Notified Body may reject incomplete applications.

Don’t take your foot off the gas !

Best practices for ensuring a smooth transition

• If you have already prepared IVDR compliant technical documentation, don’t hold back and postpone your application with a Notified Body. Remember that the Notified Body review and release of certificates may take up to 18-24 months, including multiple rounds of questions.
• If you are still working on your technical file or the generation of (clinical) performance data, you need to prioritize these activities to ensure that your application will be well ahead of the timelines stated above. Don’t wait for guidance documents.
• You can save review time and cost for Notified Body reviewer hours by ensuring your Technical File is complete and complies with IVDR. And during the review, make sure you give priority to answering Notified Body questions and providing additional documentation If requested.
• Make sure to address all applicable requirements in IVDR Annexes I – III. Use the Best Practice Guidance published by Team-NB (the Notified Body Association) and make sure you follow the specific guidance of your Notified Body, including numbering and structure of the documentation (e.g., BSI’s IVDR DocumentationSubmissions Best Practice Guidelines.
• If you haven’t done so yet, update your QMS documentation to ensure you are fully compliant with the requirements stated in IVDR Article 10 (8) and include IVDR requirements in your internal audits.

What if you are running out of time?

Qserve can support you to navigate through the IVDR transition. Understanding the expectations and the “how to” of writing technical files is key to ensure a smooth Notified Body review process. Our experts can provide training and mentoring to your staff through technical file creation to gain the benefit from our experience in working with many different IVD manufacturers.

Our IVDR services include:

• Support for selecting a Notified Body and navigating through the application process
• Notified Body like review of your Technical Files and advice for gap remediation
• Notified Body like QMS audit against ISO13485 and IVDR requirements
• Review of clinical data and advice on clinical evidence generation and study design
• Hands-on support in writing your regulatory documents /technical documentation

Contact us to learn more!