GCP R3: GCP is evolving, are you?

The ICH has released the E6(R3) revision of Good Clinical Practice (GCP), and it marks a turning point. With this update, the rules of clinical evidence have changed, and if you’re working on medical devices, SaMD or digital health, you’re in the game now too.

No need to worry, here’s a breakdown of what’s going to change and how.

Why are the GCP guidelines being updated?

As the world becomes increasingly digital, decentralized, and globally regulated, the updated ICH E6(R3) aims to align clinical trials with this paradigmatic shift.

Why is GCP changing now? Two big reasons.
The International Council of Harmonisation (ICH) has revised ICH E6 for two key reasons:

  • First, clinical research today looks nothing like it did ten years ago: with remote monitoring, decentralized trials, real-world evidence, and AI in the mix, the old rules just can’t be applied anymore.
  • Second, regulators across the globe are trying to speak the same language. Whether it’s to face the EU MDR or the AI Act, harmonized standards are the only way forward.

What changed in GCP R3?

1. The GCP is no longer a static document that gets revised every decade.
It’s now modular, with:

  • A core foundation of essential principles
  • Add-on modules that can be updated over time depending on study type

2. Explicit integration of risk-based approaches

The new GCP places risk management at the center of every stage of the clinical trial lifecycle, from study design to data oversight. This aligns perfectly with the risk-based mindset already required by the MDR.

3. Quality by Design (QbD) becomes central

Clinical quality is no longer something you “check” during an audit. Instead, quality is embedded into the design of the study from the start. This approach ensures data reliability and regulatory readiness.

What about medical devices and digital health?

If you work in medical devices, SaMD, or AI-based healthcare solutions, these changes directly impact you. Why?

All the clinical evidence you generate to

  1. Justify product safety and effectiveness
  2. Respond to notified bodies or compiling a Clinical Evaluation Report (CER)
  3. Design or conduct PMCF (Post-Market Clinical Follow-up) studies in compliance with MDR

will need to be more robust, fully traceable and aligned with modern international standards.

Even observational studies may need to align with GCP R3 principles, especially when used to support regulatory submissions under MDR or for PMCF purposes. While not all device studies are subject to full ICH GCP compliance, studies used for regulatory purposes must adhere to the fundamental principles of GCP as outlined in the new E6(R3).

This position is consistent with MDCG guidance documents such as MDCG 2020-13 and MDCG 2021-6, which recommend a risk-based and quality-centric approach to generating clinical evidence for medical devices.

The transition starts now: what are you waiting for?

By the end of July, the final version of ICH E6(R3) will be released, and the first sponsors will begin applying the new framework in study protocols currently in development.

At we4CR, we’re already adapting our planning for clinical trials involving medical devices, SaMD, and digital solutions, including post-market phases, to ensure full alignment with GCP R3.

Need help aligning your clinical study with the new GCP framework?
👉 Reach out — we’ll get your project GCP (R3) ready!

🧠 Want to dive deeper into GCP R3?

Don’t miss the next episodes of our #GCPR3Explained:
• How modularity and proportionality work in practice
• Who will be impacted (and how)
• A practical action plan to become “GCP R3 ready”

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