GSPR Checklist 2025: Key Compliance Updates for Medical Device Manufacturers
For medical device manufacturers navigating the EU market, the GSPR checklist is more than just a regulatory formality—it is the foundation of EU MDR compliance. With 2025 underway, updated interpretations and emerging expectations have made it essential to reassess the GSPR checklist with fresh eyes to ensure full compliance.
This article outlines the latest changes and the essential elements that remain critical for regulatory success this year.
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A Quick Recap: What GSPR Really Means
GSPR, as outlined in Annex I of the EU MDR, includes 23 requirements that address key aspects of a device—safety, clinical performance, usability, labeling, software reliability, and risk management. These rules apply to every device, from simple surgical instruments to complex AI-based systems.
Simply put, GSPR requires you to prove that your product is safe to use and performs exactly as intended—with evidence to back it up.
What’s New in 2025?
1.Controls on Cybersecurity and Software
Medical devices that rely on software or are digitally connected are facing tougher scrutiny. Updated expectations under GSPR 17.2 demand that manufacturers show clear documentation of:
- Cybersecurity threat assessments
- Secure development practices
- Long-term update and patching plans
Security isn’t an afterthought anymore—it must be integrated into the design from day one.
2. Greater Demand for Clinical Evidence (GSPR 1–9)
Notified Bodies are now placing more weight on clinical data, especially for higher-risk devices. Reliance on older, equivalent products is no longer enough.
Manufacturers are expected to:
- Provide direct clinical evidence for safety and performance
- Clearly connect the findings in their Clinical Evaluation Reports (CER) with GSPR 1–9
- Ensure risk management files and post-market data support each claim
3. Environmental Impact Under Review
As sustainability initiatives influence regulatory thinking, GSPR 13 and 14 are being applied more rigorously, especially in relation to:
- Hazardous substances
- Recycling and disposal processes
- Long-term environmental safety of the device and its components
Manufacturers should prepare to explain how their product supports eco-safe use throughout its life cycle.
4. AI/ML Devices: Under the Regulatory Lens
Artificial intelligence and Machine learning features are receiving increased attention. Devices must now:
- Prove the consistency and reliability of algorithms
- Demonstrate transparency in how AI makes decisions
- Validate that learning systems do not introduce bias or safety concerns after deployment
Expect detailed questions about how your AI behaves in real-world scenarios.
GSPR Areas That Remain Essential
Area | Focus | Actions to Take |
GSPR 1–9 | Safety and performance | Align with CER, risk files, usability tests, and post-market surveillance |
GSPR 10–12 | Biocompatibility and chemical safety | Use recent test data aligned with current ISO standards |
GSPR 13–15 | Hygiene and manufacturing processes | Ensure cleaning validation and traceability, especially for reusable devices |
GSPR 16–23 | Labelling and software reliability | Update instructions, verify software performance, and validate EMC compliance |
Practical Strategies for 2025
To stay ahead, manufacturers are adopting a more integrated approach to GSPR compliance:
- Build a live matrix linking each GSPR to specific documents in the technical file
- Involve design, clinical, regulatory, and quality teams early in product development
- Use software tools to automate document mapping and gap identification
- Regularly review and revise documentation based on the latest guidance and feedback.
Want To Know More about the same in Detail!
GSPR Success Starts with the Right Partner: Operon Strategist
In 2025, GSPR compliance is more than a checklist—it’s the foundation of your device’s credibility and regulatory success. Authorities expect clear, current, and well-structured documentation that proves your device is safe, performs as intended, and aligns with the latest MDR expectations.
Need expert support with GSPR compliance? Operon Strategist is here to guide you every step of the way. From building accurate documentation to navigating complex regulatory pathways, our experienced consultancy help ensure your device meets every requirement with precision. We offer tailored GSPR templates, hands-on consulting, and end-to-end support to simplify your compliance process.
Reach out to Operon Strategist to streamline your GSPR strategy and bring your medical device to market with confidence.
