EU MDR & IVDR in 2025: Mastering Transition Timelines and Compliance Strategies

The MDR and IVDR brought sweeping changes, but persistent bottlenecks led to deadline extensions. As of 2025, legacy devices benefit from staggered compliance dates, but regulators expect companies to continue advancing compliance.

MDR Deadlines:

• Class III and certain IIb implants: Dec 2027

• Other Class IIb, IIa, and up-classified Class I: Dec 2028

  
  

IVDR Deadlines:

• Class D IVDs: May 2025

• Class C IVDs: May 2026

• Class B and A sterile: May 2027

  
  

The Notified Body Bottleneck

NBs remain the scarcest resource. Long queues mean early and proactive engagement is critical. Firms must secure NB agreements, prioritize device portfolios, and respond quickly to NB queries.

PMS and Clinical Evidence

Both MDR and IVDR demand robust, ongoing evidence.

• CERs and PERs must be comprehensive, up-to-date, and linked to post-market data.

• PSURs and PMS reports are mandatory depending on class.

• PMCF/PMPF studies are increasingly expected, especially for higher-risk devices.

  
  

NBs are rejecting thin or outdated documentation. Legacy devices must be justified with fresh data, not old equivalence claims.

Technical Documentation Best Practices

• Structure files per Annex II/III with clear indexing.

• Maintain traceability from design inputs to outputs to verification.

• Address every GSPR, even with “not applicable” justifications.

• Include UDI details and EUDAMED registration.

  
  

Compliance Strategies

• Perform a portfolio assessment to triage devices by risk and revenue.

• Conduct gap analyses and build regulatory roadmaps.

• Engage NBs with realistic schedules and rapid responses.

• Close evidence gaps now with literature reviews or clinical activities.

• Update QMS procedures to MDR/IVDR standards.

• Monitor MDCG guidance and adapt quickly.

  
  

Strategic Implications

Executives must recognize MDR/IVDR as enterprise-level priorities. Non-compliance risks EU market access. CEOs should ensure resources and funding. VPs of QA/RA must lead NB relationships and documentation upgrades. R&D should integrate compliance into innovation, and portfolio managers should rationalize SKUs where compliance costs outweigh returns.

Preparing for the Future

The extensions buy time, but not immunity. MDR and IVDR compliance are already being enforced through PMS and vigilance. Firms that act now will gain smoother certifications and competitive advantage.

How PRP Compliance Can Help: We provide MDR/IVDR strategy, technical documentation support, and PMS system setup to keep your products on the EU market.