With Notified Bodies overwhelmed, the time for IVD Software Companies to secure compliance is running out.
IVDR Deadlines Are Closer Than You Think: Act Now or Risk Market Exclusion
The In Vitro Diagnostic Regulation (IVDR) is no longer a distant regulatory update - it’s an urgent crisis for many medical device software manufacturers. With the deadlines rapidly approaching, companies are facing a severe backlog at notified bodies, contract requirements, and the realization that stand-alone IVD software now requires certification. If you are not prepared, you may find yourself unable to place your product on the EU market.
The Clock Is Ticking: IVDR Compliance Deadlines Are Looming
The IVDR compliance deadline is fast approaching, with strict new requirements for medical software classification, clinical validation, and post-market surveillance. While the European Commission granted IVDR extensions, these are not a safety net- they are a warning sign. Many companies have yet to even initiate the process, mistakenly believing they have time. But here’s the hard truth: Notified bodies are overwhelmed. There are only a limited number of IVDR notified bodies, and the queue for certification is massive. If you don’t have a contract with a notified body yet, your company is already at serious risk. Without IVDR certification, your software will not be legally marketable in the European Union (EU). The transition timeframes for legacy IVDs are:
- December 2027: compliance with IVDR for Legacy IVDs Class D
- December 2028: compliance with IVDR for Legacy IVDs Class C (IVDR)
- December 2029: compliance with IDVR for Legacy IVDs Class B and Class A sterile.
IVDR Transmission milestones Image source: https://health.ec.europa.eu/document/download/93e2d43c-9da8-40b1-b6d8-8f36962c92f9_en?filename=ev_20240704_presentation.pdf If you’re not already in discussions with a notified body for IVDR, you are running out of time.
Stand-Alone IVD Software: Now a Notified Body’s Concern
Many stand-alone IVD software solutions were previously overlooked in medical device regulations. However, under IVDR medical device software compliance, most of them now fall into higher-risk classifications, requiring notified body review. If your IVD software is upscaling or integrating AI-based diagnostics, you are likely in a higher risk class. This means:
- More technical documentation requirements
- More rigorous clinical validation studies
- More regulatory scrutiny
- Longer approval timelines Ignoring this reality could mean a complete business shutdown in the EU medical device market.
Notified Bodies: A Severe Bottleneck
The reality is grim: there aren’t enough IVDR notified bodies to meet the demand. Companies that wait too long to start the process will face insurmountable delays, and some will fail to achieve certification in time. Those without established notified body contracts will find themselves pushed to the back of the queue—or outright rejected. Securing a notified body contract must be your top priority. If you have not done so, you may already be too late to meet your IVDR compliance deadline.
Act Now: What You Need to Do
If your IVD software is not yet on the compliance path, you need to act immediately:
- Secure a notified body contract: Without one, your IVDR certification process cannot begin.
- Assess your software’s risk class: Higher-risk medical software classifications require significantly more regulatory effort.
- Prepare IVDR documentation now: Delays in technical documentation submission can further slow down approvals.
- Ensure AI transparency: If your software includes artificial intelligence in medical devices, be prepared for extra regulatory hurdles under the EU AI Act.
- Prioritize usability engineering: Non-compliance with user factor engineering (HFE) can lead to IVDR certification rejection.
The IVDR crisis is real—and companies that do not act now will find themselves shut out of the EU medical device market. The deadlines are not far away, and notified bodies are drowning in requests. If you haven't started yet, the time for hesitation is over. Act now, or risk losing everything.
