The General Safety and Performance Requirements (GSPR) are a crucial component of the European Union’s regulatory framework for medical devices and in-vitro diagnostic devices, specifically under the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). These regulations aim to ensure that medical devices and IVDs are safe and perform as intended throughout their lifecycle, from design to post-market surveillance.
GSPR provides the foundational requirements that manufacturers must meet to demonstrate compliance and gain market access within the European Union.
Table of Content
Key Elements of GSPR
- Safety and Performance
Devices must be designed to meet safety standards and perform as intended in real-world conditions.
- Risk Management
Manufacturers must identify and mitigate risks throughout the product’s lifecycle. - Clinical Evaluation
Clinical evidence must demonstrate the device’s safety and performance.
- Design and Manufacturing
Devices must follow strict quality control systems during production. - Labeling and Instructions for Use
Clear, accurate labeling and instructions are required for safe use. - Post-Market Surveillance
Ongoing monitoring is needed to ensure continued safety and effectiveness.
- Traceability
Manufacturers must ensure full traceability of components and processes.
Why GSPR Matters
GSPR ensures that devices are safe and effective, helps manufacturers comply with regulations, and supports market confidence by demonstrating adherence to high standards. Meeting these requirements is crucial for obtaining CE marking and ensuring patient safety.
Why GSPR Compliance is Critical for Medical Device and IVD Manufacturers
For medical device and in-vitro diagnostic (IVD) manufacturers, compliance with the General Safety and Performance Requirements (GSPR) under the EU MDR (2017/745) and IVDR (2017/746) is non-negotiable.
Ensuring your products meet these requirements is critical:
- Patient Safety and Device Performance
The core purpose of GSPR is to ensure that medical devices and IVDs are both safe and effective for their intended use. By aligning with GSPR, manufacturers demonstrate that their products do not pose necessary risks to patients and users. - Risk Management at the Forefront
GSPR compliance requires robust risk management practices throughout the product lifecycle. From design through production to post-market monitoring, manufacturers are required to identify and mitigate risks. - Post-Market Surveillance and Ongoing Monitoring
The work doesn’t stop after a device hits the market. GSPR ensures that manufacturers have systems in place for post-market surveillance, allowing you to continuously monitor your device’s performance and address any safety or efficacy issues that arise.
The Role of a GSPR Checklist in Streamlining Compliance
When it comes to navigating the complex world of EU MDR (2017/745) and IVDR (2017/746), a GSPR checklist is an invaluable tool for manufacturers aiming to streamline compliance. With so many requirements spread across various stages of the product lifecycle, having a structured checklist can make the process more manageable, efficient, and less prone to oversight.
A GSPR checklist helps simplify complex requirements by organizing the broad range of safety, performance, and documentation standards into manageable tasks. This makes it easier to focus on what needs to be done at each stage of the product’s lifecycle, from design to post-market surveillance.
Moreover, a checklist ensures that no requirement is overlooked. With so many moving parts in the regulatory process, it’s easy to miss important steps.
By systematically working through the checklist, manufacturers can be confident they’re addressing everything from clinical evaluations to risk management, reducing the risk of non-compliance.
What is the GSPR Checklist?
A GSPR checklist is a structured tool that helps medical device and IVD manufacturers ensure compliance with the General Safety and Performance Requirements (GSPR) outlined in the EU MDR (2017/745) and IVDR (2017/746) regulations. Its purpose is to break down complex regulatory requirements into clear, actionable steps, ensuring all necessary safety, performance, and documentation criteria are met throughout the product lifecycle.
By following this checklist, manufacturers can streamline compliance, reduce the risk of overlooking key requirements, and facilitate smoother regulatory approval.
GSPR Checklist vs. the Essential Requirements Checklist under MDD/AIMDD
The GSPR checklist under the EU MDR (2017/745) and IVDR (2017/746) differs significantly from the Essential Requirements (ER) checklist under the MDD (93/42/EEC) and AIMDD 990/385/EEC) in several key ways:
- Risk Management
- MDD/AIMDD (ER Checklist): Risk management was mentioned, but the level of focus and the requirements for formal assessments were less stringent.
- MDR/IVDR (GSPR Checklist): Risk management is central to GSPR, requiring manufacturers to adopt a formal, continuous risk management process throughout the entire lifecycle of the device.
- Post-Market Surveillance and Vigilance
- MDD/AIMDD (ER Checklist): The ER checklist had some post-market requirements but with less emphasis on ongoing monitoring.
- MDR/IVDR (GSPR Checklist): The GSPR places much more emphasis on post-market surveillance, vigilance, and ongoing monitoring of the device’s safety and performance.
- Documentation and Traceability
- MDD/AIMDD (ER Checklist): While the ER checklist required documentation of essential safety and performance elements, it did not have as strong an emphasis on traceability or the need for extensive documentation across the device lifecycle.
- MDR/IVDR (GSPR Checklist): The GSPR checklist emphasizes traceability of the device and its components, requiring detailed records and comprehensive documentation that are accessible and maintained throughout the product’s life.
While the Essential Requirements checklist under the MDD/AIMDD focused on basic safety and performance principles, the GSPR checklist under the MDR/IVDR takes a much broader, more detailed approach, incorporating enhanced requirements for risk management, clinical evaluation, post-market surveillance, and traceability, reflecting the EU’s move to a more stringent and comprehensive regulatory environment.
Key Components of the GSPR Checklist
The GSPR checklist under the EU MDR (2017/745) and IVDR (2017/746) ensures that medical devices and IVDs meet essential safety, performance, and regulatory requirements.
- Risk Management & Benefit-Risk Analysis
Manufacturers must implement a risk management process to identify, assess, and mitigate potential hazards throughout the product lifecycle. A benefit-risk analysis is required to ensure the benefits of the device outweigh its risks, with ongoing monitoring and updates as needed. - Biocompatibility & Clinical Evidence
Devices in contact with the human body must undergo biocompatibility testing to ensure no adverse reactions. Clinical evidence, through trials or literature reviews, must be provided to demonstrate the device’s safety, effectiveness, and compliance with GSPR requirements. - Usability & Labeling Requirements
Devices must be designed for ease of use, reducing the risk of misuse. Clear, accurate labeling and instructions must be provided, including safety warnings and usage guidelines, to ensure proper and safe use by all users. - Post-Market Surveillance & Vigilance
Manufacturers must have a post-market surveillance plan in place to monitor the device’s performance after launch. This includes reporting adverse events, conducting periodic safety reviews, and implementing corrective actions as necessary to address any issues.
The GSPR checklist helps manufacturers ensure their devices are safe, effective, and compliant throughout their lifecycle, from design and clinical evaluation to post-market surveillance.
Common Challenges in Completing the GSPR Checklist
Completing the GSPR checklist under EU MDR and IVDR can be challenging due to several key factors:
- Interpreting Requirements Correctly
The GSPR includes complex and detailed requirements, which can be difficult to interpret, especially for specific devices. Misunderstanding these regulations or how they apply can lead to incomplete compliance and potential delays in market approval. - Keeping Up with Evolving Regulatory Expectations
Regulatory expectations under the EU MDR and IVDR are constantly evolving, making it hard for manufacturers to stay updated. Adapting to new rules and maintaining compliance requires continuous monitoring and can be resource-intensive. - Managing Documentation Efficiently
With extensive documentation required for GSPR compliance – ranging from clinical evidence to risk management reports – organizing and keeping it up to date can be overwhelming. Inefficient documentation practices can cause delays or non-compliance issues during audits or regulatory reviews.
Manufacturers face challenges in interpreting GSPR requirements, staying aligned with changing regulations, and managing extensive documentation. Addressing these issues is key to ensuring smooth compliance and market access.
How RegDesk Simplifies GSPR Compliance
RegDesk makes GSPR compliance easier for medical device and IVD manufacturers through innovative AI technology and automation:
- AI-Driven Regulatory Intelligence for Up-to-Date Requirements
RegDesk’s AI-powered system ensures manufacturers stay current with the latest GSPR requirements, automatically updating them on regulatory changes in real-time. - Automated Checklist Generation Tailored to Specific Products
RegDesk generates customized GSPR checklists tailored to each product, covering all relevant safety, performance, and documentation requirements, saving time and ensuring thorough compliance. - AI-Enabled Form Builder for Help in Creating Form
RegDesk’s AI form builder simplifies creating complex regulatory forms and documents, automating the process based on device details and intended use. - Seamless Documentation Management to Streamline Submissions
With integrated documentation management, RegDesk helps manufacturers organize and store all compliance documents in one place, making audits and submissions faster and easier.
Recap of the Importance of the GSPR Checklist
In conclusion, the GSPR checklist is crucial for ensuring that medical devices and IVDs meet the safety, performance, and regulatory requirements outlined under the EU MDR and IVDR. It helps manufacturers navigate complex regulations, stay compliant, and reduce the risk of delays in approval and market entry.
Best Practices for Staying Compliant
To stay compliant, manufacturers should regularly review and update their compliance processes, thoroughly document all stages of product development, and ensure ongoing risk management. It’s also vital to stay current with evolving regulations and seek expert guidance when needed.
How Leveraging RegDesk’s Technology Can Help Manufacturers Accelerate Compliance and Market Entry
By leveraging RegDesk’s AI-driven tools, manufacturers can simplify and accelerate compliance. Automated checklist generation, AI-enabled form builders, and seamless documentation management help streamline the process, reduce manual effort, and ensure faster regulatory submissions.
With RegDesk’s technology, manufacturers can achieve quicker market entry while maintaining full regulatory compliance.
Author: Taylor Esser
