IVDR Transition Deadline: What to Do If [Odds Are] You're Behind

As the IVDR transition deadlines approach (and pass by), the time for waiting is over. 

What "Behind" Really Means 

We've been trying to help our industry colleagues be well prepared to meet compliance timelines; past, imminently present and future. But we keep seeing IVD manufacturers look at final transition deadlines and think they have time. If they haven’t already fallen out of compliance and think they are “OK,” they haven't done the math working backwards. 

Here's the reality: if you are a IVD manufacturer with devices on the market in the EU under IVDD certification, you are quite likely farther behind than you think.  

You're Already Non-Compliant with IVDR If... 

Your QMS isn't IVDR-compliant (Deadline passed: May 26, 2025) 

To remain eligible for the IVDR transition period, legacy IVD manufacturers were required to have a fully IVDR-compliant Quality Management System (QMS) in place by May 26, 2025. Devices without a compliant QMS by that date lost their transition eligibility and must not be placed on the EU market without full IVDR certification. 

Note: Having in place a QMS complaint with IVDR by 26 May 2025 is a regulatory requirement for any transition device. Manufacturers that do not fulfill this requirement will not be able to maintain their devices on the market as transition devices.  

Furthermore, your post-market surveillance (PMS) system should already be in place and comply with relevant IVDR requirements. If you are waiting to start PMS and post-market performance follow-up (PMPF) activities, you’re behind. Under IVDR, manufacturers (including legacy manufacturers) are obliged to proactively collect and evaluate performance and relevant scientific data from the use of a device.  

You're a manufacturer of a Class D device without a signed Notified Body contract (Deadline passed: September 26, 2025) 

As a Class D device manufacturer you should have lodged a formal application to a Notified Body by May 26, 2025 and signed a contract by Sep 26, 2025. Without a signed contract, you will not only be facing significant delays you and have also lost your transition eligibility. 

The Math Problem Everyone's Ignoring on the IVDR Transition Deadline

Companies look at the IVDR transition deadline - December 31, 2027 (Class D) or December 31, 2028 (Class C) - and think they have runway. The 18 to 24 months everyone talks about is ONLY the Notified Body conformity assessment time. That doesn't include the months of work you need to do before you can even submit. 

Let's do the math for Class D: 

• Final deadline: December 31, 2027 (25 months from now) 

• Notified Body review time: 18-24 months minimum (just the assessment) 

• Technical documentation preparation: 6-12 months (before submission) 

• If you need clinical performance studies with prospective data collection: add 12-24 months 

The total time needed is 24 to 36 months. You have [less than] 25 months remaining. The window hasn’t closed if you haven't started, but every passing day means compressed timelines for complicated tasks and Notified Bodies that will certainly be flooded with a backlog of “urgent” review requests of dubious and varying quality. 

For Class C devices: 

Your final deadline is December 31, 2028. Contact a Notified Body by May 2026, sign contract by September 2026 to benefit from the transition period. Assess the current technical documentation and how existing data corresponds to the current claims and intended use of the device. If a gap in data is identified you may consider to either adjusting the intended use and claims or collecting more data by leveraging PMS/PMPF activities. If this is not possible and a prospective clinical performance study is needed, you may already be behind (12-24 months is needed for ethics approval, protocol design, patient recruitment, and data collection). 

For Class B and Sterile Class A devices: 

Your deadline is December 31, 2029. But approximately 80% of legacy devices are Class B and C combined. When this wave hits the 19 Notified Bodies designated for IVDR, capacity will disappear. Manufacturers who start now have options. Those who wait will be at the back of a long queue. 

Editor’s note: Number of EU Notified Bodies as referenced and linked above is current as of November 29, 2025 and subject to change over time as new Notified Bodies are added. 

The Experience Gap in IVDR Conformity Assessment 

The IVDR represents a fundamental shift in how IVD manufacturers demonstrate compliance. Many companies that operated under self-declaration for years now require third-party certification for the first time. Performance evaluation requirements have evolved significantly. Clinical evidence standards are higher. Expectations on Technical documentation are now prescriptive in the IVDR. 

Very few organizations have completed the full IVDR conformity assessment process yet. When evaluating partners to support your transition, consider: Have they brought Class D devices to CE mark under IVDR? Successfully supported clinical performance studies accepted by Notified Bodies for IVDR purposes? Do they have team members who've served on ISO technical committees or worked directly with Notified Bodies? Do they have team members that really understand IVD technologies and IVD development? 

At Veranex, we've supported clients through successful conformity assessments across multiple designated Notified Bodies. Our team includes former Notified Body staff who understand the review process from both perspectives.
 

If You're Panicking: Your IVDR Action Plan Should Include the Following.

1. Portfolio Strategy and Device Grouping

For Class B and C: group devices into families for conformity assessment to reduce time and cost significantly. Map your portfolio, understand logical groupings, and prioritize by commercial importance, complexity, and deadline. This determines your entire regulatory approach. 

2. Gap Assessment - Technical Documentation and Performance Evaluation

Start with a comprehensive gap assessment of your Technical Documentation, specifically your Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER). This will tell you how you'll cover the performance requirements for your device. 

Don't assume you know where you stand. Companies consistently underestimate their gaps. 

To ensure alignment across all Notified Bodies, the Team-NB has made a significant effort to harmonize expectations by issuing a guideline (now version 2). Please use this guideline when building the Technical Documentation according to Annex II and III of IVDR2.   

3. Identify What's Missing and How Long It Will Take 

Hard truths from your gap assessment: 

• Additional clinical performance data needed? 

• IVDR-compliant Risk Management File? 

• Post-market surveillance data for PMS Plan/Report? 

• Usability studies for near-patient testing devices? 

Risk management you can do in-house. Collection of patient data requires ethics approvals, competent authority submissions, study design, and execution. That's 12+ months minimum. 

4. Engage a Notified Body Through Structured Dialogue

Don't wait for perfect documentation. Use structured dialogue to align on strategy, understand expectations, and get feedback before formal submission. 

Different Notified Bodies have different interpretations and expertise areas. While capacity exists, you have options. That won't last. The only way to compress conformity assessment time is outstanding technical documentation that makes the reviewer's job easier. 

The IVDR Reality Check You Need 

We believe 80% of companies requiring this work are farther behind than they realize. If you think you have time, let us validate that. We won't sugarcoat it. If you're behind, we'll tell you exactly how far behind and what it takes to recover. 

Contact us for comprehensive IVDR transition support. We can tell you where you stand, develop your regulatory strategy, and execute the technical documentation, performance evaluation, and clinical work needed to meet your deadline. From gap assessment through Notified Body certification, we've successfully guided manufacturers through this exact transition. 

Veranex supports IVD manufacturers through every stage of IVDR transition. Our regulatory and clinical teams have successfully brought Class D devices to CE mark under IVDR, with accepted clinical performance studies and conformity assessments across multiple Notified Bodies. We have former Notified Body staff and ISO technical committee members employed. We know this regulation because we've lived it with our clients.

About the authors: 

Silvia Anghel, PhD, has a unique combination of scientific research expertise and extensive industry experience in the field of in vitro diagnostics (IVD). Her distinguished background includes research conducted in prestigious laboratories across Canada and Switzerland, focusing on oncology, metabolism-related disorders – including cardiovascular diseases –, and gastroenterology. She has more than 15 years of industry experience, managing projects related to the development, manufacturing, regulatory compliance and quality management of IVD devices. At Veranex, Silvia guides manufacturers through regulatory pathways and performance evaluation strategies, leveraging her comprehensive understanding of product lifecycles from development through commercialization. She provides strategic guidance in quality management system implementation, technical documentation development, and critical negotiations with Competent Authorities and Notified Bodies, making her an invaluable resource for companies navigating the complex IVD regulatory landscape.

Sofia Spjuth, Vice President of Clinical Affairs, Europe is a medical device engineer with 10+ years of experience within the medtech industry. She is a member of SIS/TC 340 and SIS/TC 331, Technical Committees established to defend Swedish interests and influence the European and global standardization work in the field of medical devices; implants, biological safety, biocompatibility, clinical investigations, laboratory medicine and biotechnology. Sofia is also nominated as a Swedish expert in ISO/TC 194 WG 4 clinical investigations of medical devices and participated in the establishment of ISO 14155:2020.

Citations:

1. MedTech Europe, "IVDR & MDR Survey Results 2024," www.medtecheurope.org. 

2. Team-NB Position Paper Editor : Team-NB Adoption date 03/09/2025 Version : V2 Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746