GSPR in EU MDR Checklist
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Description
The General Safety and Performance Requirements (GSPR) is an essential part of the EU MDR. The GSPR sets out the safety requirements for medical devices that ensure compliance with EU MDR. These requirements cover safety, design, manufacturing, and performance.
What is GSPR in EU MDR?
The GSPR sets out the safety requirements for medical devices that ensure compliance with EU MDR. These requirements cover safety,risk management, device lifecycle, design, manufacturing, and performance.
The GPSR includes provisions related to areas of design, risk,intended purpose, clinical evaluation, post market surveillance, labeling, IFU, etc. Manufacturers must address it to obtain CE marking for market access in the EU.
How to perform gap assessment for GSPR?
Performing a gap assessment includes evaluating the compliance of a medical device to the MDR or IVDR. The first step is to understand GSPR requirements, review regulations, gather documentation, perform gap analysis, identify gaps, create an action plan, implement corrective actions, verify compliance, document evidence, and continual improvement.
What is included in this product?
Rook Template EU MDR GSPR Requirements Gap Instructions
The instructions show how to use the gap analysis and an outline for the General Safety and Performance Requirements (GSPR) are listed in Annex I of EU MDR 2017/745. The GSPR has 23 requirements under MDR and the chapters are broken down into the following subcategories which translate into each sheet within our GSPR excel template.
Rook Template EU MDR GSPR Requirements Gap Analysis
The Gap analysis includes requirements for performance and safety of the device, device related risks, risk management system, risks from user error, manufacturing, packaging, transport and storage of the device, benefit-risk ratio, and medical purpose. This ensures eu 2017/745 compliance with essential requirements, active devices, and patient safety.
