The MDR deadline extension is not a pause. It’s a strategic opportunity – but only if you act early.

Back in early 2024, the European Commission granted more time for companies to align with Regulation (EU) 2017/745 (MDR) – particularly concerning legacy devices. While many manufacturers welcomed the extra breathing room, be careful: more time doesn’t mean fewer obligations.

In our previous article (“MDR: Racing Against Time”), we addressed how to:

  • Prevent your MDD certificate from expiring
  • Secure your CE Mark under the new MDR timeline
  • Plan compliant clinical investigations without delay risks

MDR 2025: The 4 Key Changes You Can’t Ignore

1. Implant Cards: Greater enforcement from 2025

While the Implant Card requirement (Article 18 MDR) has officially been in place since 2021, 2025 marks the point of stronger implementation and operational harmonization across Member States.
Manufacturers must ensure:

  • Patient-accessible, multilingual and electronically updatable information
  • Alignment with the EUDAMED database and UDI systems
  • Full traceability and data integration

Common pitfalls: lack of standardized templates, delays in digital process automation, and incomplete patient materials.

2. Real-World Evidence and PMCF: more demanding expectations

The 2025 landscape brings a more data-driven approach to Post-Market Clinical Follow-up (PMCF), including:

  • Use of real-world data (RWD) from clinical registries and interoperable health databases
  • PSURs enriched with safety trends and clinical outcomes
  • Observational studies as key support for Clinical Evaluation Reports (CER)

Guidelines like MDCG 2022-2, 2020-6, and 2020-7 reinforce this shift – even for “stable” devices already on the market.

3. AI Act + MDR: Dual compliance for AI-based SaMD

With the AI Act approved in May 2024, manufacturers of AI-powered medical software (SaMD) will need to demonstrate compliance with both the MDR and the AI Act.

Although the Predetermined Change Control Plan (PCCP) concept is formally recognized under FDA guidance, its core principles (transparency in algorithm lifecycle and changes) are gaining traction in Europe as well.

Manufacturers must now document:

  • Algorithm lifecycle management (training, updates, bias mitigation)
  • Parallel regulatory alignment (AI Act + MDR)
  • Internal processes to control and report predefined changes to AI systems

4. Clinical Investigations and CAP: Europe-wide coordination expands

The Coordinated Assessment Procedure (CAP) is not new – but from 2025 onward, it is expected to become a standardized pathway for multicenter clinical investigations under MDR.

This brings both opportunities and new demands:

  • Simplified access to multiple EU markets
  • Need for harmonized submission dossiers
  • Simultaneous communication with multiple national authorities

Those unfamiliar with CAP may face delays. But companies who prepare thoroughly will gain a significant regulatory advantage.

How We4CR Can Support Your MDR 2025 Transition

We4CR helps you build a clinical and regulatory strategy that matches the complexity of MDR 2025. Our services include:

  • Updating your technical documentation (CER, PSUR, PMCF, Implant Card)
  • Aligning SaMD compliance under both MDR and AI Act
  • Designing and managing CAP-compliant clinical studies from submission to follow-up

We’re more than consultants: we work alongside your team to reduce risk and accelerate CE marking.

Take Action Now: Book a Free MDR 2025 Strategy Call

The clock is ticking. The time gained through the MDR extension is almost up.

Act now, and you’ll move forward with clarity, compliance, and a strong competitive edge.
Wait too long, and you risk delays, nonconformities, and rework.

Book your free call with We4CR – we’ll assess your MDR readiness and provide a customized roadmap to full 2025 compliance.

Missed the first part of this guide? Read our article on managing the MDR extension and CE Marking without delays → [MDR: Racing Against Time for Your CE Mark]