IVDR Transition Deadline What Happens After May 26, 2025

The May 26, 2025, IVDR transition deadline is quickly approaching, marking a critical milestone in the European In Vitro Diagnostic Medical Devices Regulation (IVDR). For many manufacturers, this deadline represents the last opportunity to continue placing certain legacy IVDs on the market under transitional provisions—provided that specific requirements are met by that date. 

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What’s Changing After May 26, 2025? 

After this deadline, only legacy IVD devices that meet the following conditions may continue to be placed on the market: 

• The manufacturer has classified their legacy device according to IVDR classification rules. 

• The manufacturer has documented evidence of IVDR-compliant Quality Management System (QMS) implementation (e.g., ISO 13485 certificate or self-declaration). 

• For IVDD-certified devices and/or IVDs that will be Class D IVDs under the IVDR, the manufacturer holds an acknowledgement letter of their application from the Notified Body involved.

Manufacturers who have not yet lodged a formal application to a Notified Body must act immediately.

Without meeting all transitional provisions, manufacturers will no longer be permitted to place those products on the market in the EU or associated markets like Switzerland.

What to Expect After the IVDR Transition Deadline 

While this deadline feels definitive, it’s important to recognize that IVDR implementation and enforcement will continue to evolve well beyond May 2025. Here’s what manufacturers should be prepared for next: 

1. Increased Notified Body (NB) Oversight 

With thousands of applications under review, Notified Bodies will continue to process IVDR conformity assessments for the upcoming years. Manufacturers of higher risk IVDs will go through in-depth NB technical documentation reviews and on-site audits as part of the CE certification process. The pressure on Notified Bodies remains high, so timely responses and maintaining open communication with your NB will be essential. 

2. Market Surveillance and Enforcement by Competent Authorities 

After May 26, 2025, Competent Authorities and Market Surveillance Authorities will likely begin stepping up checks to ensure that only compliant legacy devices remain on the market. This includes verifying that manufacturers have the required documentation and agreements in place. Manufacturers should keep their records ready for inspection and be prepared to demonstrate compliance at any time. 

3. Ongoing Post-Market Vigilance Requirements 

Even legacy devices under transition remain subject to IVDR post-market surveillance, vigilance, and reporting obligations. Manufacturers must continue to monitor performance, manage incidents, and submit reports as required by IVDR. Failure to maintain these activities could result in loss of market access, even if transitional conditions were met by the deadline. 

4. Transitioning Legacy Devices to Full IVDR Certification 

The transitional provisions do not exempt manufacturers from eventually obtaining full IVDR certification. The May 2025 milestone is only one step in a larger journey. Based on the classification of their IVDs, manufacturers should have a clear regulatory strategy to transition all legacy devices to IVDR-certified status as quickly as possible. 

5. Regulatory Divergence in Switzerland and the UK 

Manufacturers should also be aware of evolving requirements in associated markets like Switzerland and the UK. Swissmedic, for example, has adopted transitional rules for IVDR-equivalent devices but has introduced additional market-specific requirements, including swissdamed registration. The UK has its own future regulatory updates planned, so manufacturers must monitor these developments to stay compliant in all markets they serve. 

Our Expert Insight: Stay Ahead by Planning Proactively 

At MedEnvoy, we continue to see manufacturers underestimate the time and effort required to gather documentation, secure Notified Body agreements, and manage the operational impact of these regulatory changes. Waiting until deadlines pass such as the IVDR transition deadline, often results in lost market access or rushed submissions that may fail to meet Notified Body expectations. 

We recommend that manufacturers: 

• Complete internal reviews now to confirm you have all the required documentation in place. 

• Engage with your Notified Body early and often to avoid processing delays. 

• Evaluate your post-market processes to ensure IVDR vigilance and surveillance activities are fully implemented. 

• Plan for long-term certification beyond the transition deadline. 

Additionally, for manufacturers who work with multiple Authorized Representatives or other Economic Operators like the distributor and importer, now is the time to confirm that all parties are aligned on their roles in post-market surveillance and regulatory communication. 

How MedEnvoy Can Help 

As your dedicated regulatory partner, MedEnvoy can support your organization in navigating IVDR transition requirements including deadlines, maintaining market access, and preparing for full IVDR certification. Whether you need support with documentation review, Authorized Representation, Regulatory Importer, swissdamed registration, or market-specific strategies, we’re here to help. 

Contact us to speak with our regulatory experts and learn how we can support your IVDR compliance efforts.