GSPR: The Key to Unlocking Regulatory Success in Medical Device Projects
Embarking on a medical device project is an exciting journey, yet fraught with regulatory hurdles. Among these, the General Safety and Performance Requirements (GSPR) in Annex I of EU MDR 2017/745 serve as the cornerstone for ensuring regulatory compliance and product safety. Many manufacturers mistakenly treat GSPR as just a “checkbox,” but in reality, it is the foundation of a successful medical device project.
This blog explores why GSPR should be central to your project planning and how it supports achieving compliance, managing risks, and streamlining technical documentation.
Looking For a Medical Device Regulatory Consultant?
Let’s have a word about your next project
What is GSPR and Why Does It Matter?
GSPR outlines the essential safety and performance criteria that medical devices must meet to comply with the EU MDR. It ensures your device is not only safe but also performs as intended under normal and foreseeable conditions.
Ignoring GSPR during the early stages can lead to costly rework, project delays, or even failure to achieve CE marking—the gateway to the European market.
Why Start Your Project with GSPR?
- Defines the State of the Art
GSPR helps establish the “state of the art” by identifying recognized standards and best practices. Integrating these from the beginning ensures that your device is built on a solid foundation.
- Guides Risk Management
Each GSPR includes inherent risk control measures, making it an invaluable resource for your device’s risk management process. Addressing these early reduces the likelihood of non-conformance during audits.
- Serves as a Blueprint for Technical Documentation
The GSPR checklist acts as a roadmap for developing and organizing your Technical Documentation (TD). It ensures all necessary evidence and compliance documents are aligned with regulatory expectations.
Key Steps to Build GSPR Compliance
- Determine Applicability
Not all GSPRs apply to every device. For example, if your device is a hip prosthesis, GSPRs related to electronics may not be relevant. For each GSPR:
- Identify its applicability.
- Document why certain requirements are not applicable.
- Apply Harmonized Standards or Common Specifications
Leverage harmonized standards and Common Specifications (CS) to demonstrate presumed compliance. These standards simplify your compliance journey but are not mandatory, allowing flexibility to define alternative approaches.
- Collect Evidence and Define Methods
For each applicable GSPR, gather objective evidence demonstrating compliance. Define methods like testing protocols, clinical evaluations, or risk analyses to substantiate your claims.
GSPR and Technical Documentation: An Interconnected Ecosystem
The GSPR checklist directly influences how you compile technical documentation, which is more than just a collection of files. It is a dynamic system that evolves with new data. Here’s how GSPR links to technical documentation:
- Evidence Mapping: Each GSPR corresponds to specific sections of the TD, ensuring every requirement is backed by objective evidence.
- Consistency: GSPRs drive coherence across documents, minimizing duplication and ensuring clarity.
Benefits of Early GSPR Integration
- Faster Time-to-Market
By addressing GSPR from the outset, you reduce the risk of delays during the CE marking process.
- Reduced Compliance Costs
Proactively integrating GSPR into design and development minimizes the need for costly rework or repeat testing.
- Audit Preparedness
A robust GSPR approach ensures your TD is always audit-ready, providing confidence during regulatory inspections.
Start Your GSPR Journey with Operon Strategist
Navigating the complexities of GSPR and EU MDR compliance requires expertise and meticulous planning. Operon Strategist specializes in regulatory consulting and turnkey solutions for medical device manufacturers. From creating GSPR checklists to developing technical documentation, we help streamline your path to compliance.
Why Choose Operon Strategist?
- Expert guidance on GSPR applicability and evidence collection.
- Comprehensive templates for GSPR and technical documentation.
- Tailored solutions for CE marking and EU MDR compliance.
Ready to simplify your medical device compliance?
Conclusion
Integrating GSPR at the beginning of your medical device project is not just a regulatory formality—it is a strategic decision that drives compliance, risk management, and product success. By viewing GSPR as a foundation, you set your project up for smoother development and faster regulatory approvals.
