Regulatory curve-balls every EU device maker must catch this year.
1. Booking a Notified-Body (NB) slot before the queue backs up again.
Just 51 designated NBs are covering 25,000+ “legacy” certificates plus all new devices [1]. Fresh BSI figures (Jun 2025) show lead-times of 12-18 months for Class IIb/III reviews.
2. Generating solid clinical evidence & risk management files.
Regulations (MDCG 2024-5) give a 30-page checklist-style spec for IB content, including fuller risk-management linkage and data plans [2]. NBs are rejecting dossiers that rely on “equivalence” alone.
3. Showing the device is cyber-secure and AI-Act-ready.
Now high-risk “Medical Device AI” must satisfy both MDR and the EU AI Act. That adds data-governance, transparency and post-market monitoring layers. Guidance released in June 2025 emphasizes “security-by-design” and patch management – topics NBs now quiz in depth [3].
4. Getting UDI & EUDAMED data in before the hard switch-on.
The Commission confirmed the UDI/Device module should be fully functional by Q2 2025 and mandatory on 1 Jan 2026. Actor and Certificate modules are already live. Experience says the real deadline is late-2025 [4]; IT teams, consultants and NB portals will all be jammed by then, so clean, machine-readable data pipelines should be ready now.
5. Proving material compliance.
The EU’s wide-ranging ban could restrict some fluoropolymer parts and coatings by 2026–2027. Scientific analyses warn of “collapsed supply chains” if exemptions are short [5]. Choosing alternative materials today – or documenting a robust essential-use justification – is needed to avoid re-certification or withdrawal.
Here’s to every med-tech team turning bold ideas into safer care – may your CE marks land smoothly and your patients thrive!
*UDI – Unique Device Identifier; EUDAMED – European Database on Medical Devices
