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- Audit Readiness: Develop a structured, evidence-based checklist to facilitate Notified Body assessment. Because It is often the first document a Notified Body auditor will review.
- Documentation Consistency: Ensure traceability and alignment with your Risk Management File, Clinical Evaluation Report, and other technical documentation.
- Standards Compliance: Identify applicable harmonised standards and support the demonstration of conformity with relevant GSPRs.
- Regulatory Support: Help manufacturers establish documented evidence of conformity to support the CE marking process.
Understanding the General Safety and Performance Requirements (GSPR)
The General Safety and Performance Requirements (GSPR), outlined in Annex I of EU MDR 2017/745 and IVDR 2017/746, define the fundamental safety, performance, and risk management criteria that medical devices and IVDs must meet. Demonstrating compliance with the applicable GSPR is a mandatory requirement for CE marking and provides evidence that the device is safe, effective, and compliant throughout its intended lifecycle.
GSPR Structure under EU MDR and IVDR
The GSPR is organized into 3 key sections:
Chapter I – General Requirements
This section focuses on device safety, intended performance, risk management, benefit-risk assessment, and the protection of patients, users, and other persons throughout the device lifecycle.
GSPRs 1-9: These are the foundational principles ensuring the device performs as intended throughout its lifetime.
1-8: General Application to All. (Design & Risk)
9: Devices referred to in Annex XVI - Groups of Products Without an Intended Medical Purpose Referred to in Article 1(2)
Chapter II – Requirements for Design and Manufacture
This section addresses the technical aspects of device design and development, including biological safety, chemical and physical properties, software, electrical safety, infection control, usability, active devices, and performance-related requirements.
GSPRs 10-22: These are specific technical requirements related to the device’s characteristics.
10: Chemical, Physical, Biological (CMR, Endocrine Disrupting, Phthalate, their labelling)
11: Microbial (Cleaning, Disinfection Sterilization, Re-use, labelling)
12: Medicinal (Directive 2001/83/EC)
13: Biological origins (Directive 2004/23/EC, 2002/98/EC, Reg. 722/2012)
14: Constructions of Device (Interphase, operating req),
15: Diagnostic Measurement (Directive 80/181/EEC)
16: Protection against Radiation
17: Electronic programmable systems / Software
18: Active Device
19: Active Implantable
20: Protection against Mechanical & Thermal
21: Protection against device supplying energy and substances
22: Protection of lay person Device usage
Chapter III – Information Supplied with the Device
This section defines requirements for labeling, Instructions for Use (IFU), Unique Device Identification (UDI), packaging information, and other information necessary for the safe and effective use of the device.
Together, these requirements ensure that devices placed on the European market achieve the highest standards of safety, performance, and regulatory compliance.
GSPR 23
23.1: general Principle of Information Delivery
23.2: Mandatory Information as per Specification
23.3: Sterile Packaging Requirement
23.4: IFU requirement
Demonstrating Compliance with GSPR: Annex II of the EU MDR and IVDR requires manufacturers to document how each applicable GSPR has been addressed within the Technical Documentation. Compliance must be supported by objective evidence demonstrating conformity with the applicable requirements of Annex I. A robust GSPR Checklist serves as a critical component of the Technical Documentation and supports successful conformity assessment and CE marking.
GSPR Checklist Preparation
The GSPR Checklist is prepared with cross-functional team input.
- Design & Development: Design specifications and Verification &Validation evidence
- Risk Management: Risk assessments and control measures
- Clinical Affairs: Clinical evaluation evidence
- Usability Engineering: Evidence demonstrating compliance with applicable usability-related GSPRs.
Our expertise helps manufacturers establish a complete, evidence-based GSPR Checklist with clear traceability to technical documentation.
The GSPR Checklist is a critical component of the Technical Documentation required under Annex II of EU MDR 2017/745 and IVDR 2017/746. It provides a systematic assessment of each applicable General Safety and Performance Requirement (GSPR) set out in Annex I and demonstrates how conformity has been established through objective evidence.
The checklist identifies applicable and non-applicable GSPR provisions, provides justifications for exclusions where relevant, references applicable harmonized standards, Common Specifications (CS), and other conformity assessment methods, and establishes clear traceability to supporting documentation within the Technical File. This may include risk management records, verification and validation reports, biological evaluation, clinical or performance evaluation documentation, usability engineering files, labeling, and post-market surveillance documentation.
A well-structured GSPR Checklist serves as a comprehensive conformity matrix, facilitating regulatory review and demonstrating compliance during conformity assessment procedures, notified body audits, and CE marking activities.
Key Considerations for GSPR Compliance
Effective GSPR compliance requires continuous risk management, comprehensive technical documentation, and clear evidence demonstrating device safety and performance. Manufacturers must establish traceability between GSPR requirements, applicable standards, testing activities, and supporting documentation to successfully demonstrate conformity and maintain regulatory compliance throughout the device lifecycle.
Method of Conformity: The method used to prove compliance, typically by referencing a specific harmonized standard (e.g., EN ISO 14971:2019), a Common Specification, MDCG guidance, or an internal procedure.
