The Dawn After the Deadline: Where EU IVD Manufacturers Stand

It is estimated that 1,203 IVDR certificates have been issued since January, with Class D devices comprising of many of these approvals. While these figures suggest progress, they also highlight persistent challenges: Many notified bodies report technical documentation gaps in recent applications, particularly around clinical evidence requirements...

What does this mean for your business? The pressure is on to ensure your compliance team isn’t just in place, but fully equipped to handle ongoing examination. Whether you’re maintaining existing certifications or catching up after missing the initial deadline, the right people (and the right skills) are now the difference between market access and costly delays.

 

Building Future-Proof Teams in the New Regulatory Era

Core Roles Driving Compliance Success:

The regulatory strategist remains pivotal in this post-deadline phase.
These professionals now navigate dual priorities - shepherding pending applications through notified body reviews while implementing Article 110(3c) requirements for legacy devices. The most sought-after candidates demonstrate fluency in translating MDCG 2025-7 guidance on hybrid audits into practical workflows. 

Documentation specialists have evolved into clinical evidence architects under IVDR pressures. With Class C and D devices requiring approximately 300-400 hours of technical file preparation, many manufacturers increasingly seek professionals holding dual qualifications in regulatory affairs and molecular biology. MedtechEurope notes that 78% of IVDs now require notified body involvement (up from 8% under the IVDD), necessitating deeper technical expertise in performance evaluation and risk management.

Five Critical Competencies for 2025 Compliance Leaders

Adaptive risk management tops the skills checklist as manufacturers reconcile legacy systems with IVDR mandates. Successful quality managers excel at implementing Annex VIII risk classifications without disrupting supply chains - a balance many EU manufacturers are recognising as their top challenge in Q1 2025 surveys.

Cross-functional communication skills prove equally vital. With the majority of delayed applications attributed to misalignment between R&D and regulatory teams, the ability to mediate technical and compliance priorities becomes paramount. Leading organisations address this through rotational programmes that embed quality specialists in product development cycles.

Emerging Trends in Post-Deadline Recruitment

The June 2025 hiring landscape reveals three key patterns:

1. Upskilling surges
   Diagnostic companies are investing significantly (often tens of thousands of euros in aggregate on training programs) per team member per employee in IVDR-specific training, focusing on PMPF strategy development and EURL collaboration protocols.

2. Fractional leadership demand
   Many SMEs now use interim quality managers to bridge skills gaps, paying around €950–€1,350 daily for experts who can implement Article 10(8) QMS requirements.

3. Global talent pipelines
   With Munich and Amsterdam emerging as regulatory hubs, EU manufacturers are recruiting from Commonwealth countries to access IVDR-experienced professionals.

 

Your Path Forward

For manufacturers navigating post-deadline complexities, three strategies prove effective:

• Implement phased knowledge transfer Pair new hires with legacy staff through mentorship programmes that capture institutional knowledge about hybrid IVDD/IVDR systems.

• Leverage regulatory technology AI-driven gap analysis tools could now map team competencies against IVDR annex requirements in less time than manual audits. Look for platforms with MDSAP integration capabilities to streamline global compliance.

• Build notified body relationships With certification timelines stretching to 24 months for complex IVDs, proactive communication with assessment teams is crucial. Monthly technical update briefings can prevent application delays.

 

Struggling to keep up with IVDR? You don’t have to do it alone.

Whether you’re racing to close documentation gaps, scaling your QMS team, or searching globally for IVDR-experienced professionals, the right talent is mission-critical.

Our team here at Panda, can support you in connecting diagnostics companies with compliance leaders who don’t just meet the standard – they define it.

Get in touch if you want to meet IVDR-ready specialists who can step in, scale up, and keep your innovation on track.