General Safety & Performance Requirements
GSPR Medical Devices (General Safety & Performance Requirements)
Every Medical Device that undergoes a conformity assessment procedure for the European market must comply with the General Safety & Performance Requirements (GSPRs), also known as GruSuLa in German, set out in Annex I of the European Medical Device Regulation (MDR). This applies to all types of devices, from simple adhesive bandages to advanced imaging systems like CT scanners.
These General Safety and Performance Requirements constitute a catalog of requirements for essential criteria that a medical device must meet as a minimum.
For each requirement, the following criteria must be assessed:
- Does the requirement apply to your product? If it does not apply, provide a clear justification.
- Which standard demonstrates compliance? You must identify the applicable harmonized or relevant standard.
- Which supporting document demonstrates compliance? Test report, risk analysis file, clinical evaluation. Directly referenced in the catalog.
Only this link between the requirement, the standard, and the supporting documentation makes the catalog a reliable component of your technical documentation. The section Practical Implementation shows how this works step by step.
The legal basis is derived from Article 5 and Article 10 (manufacturers’ obligations) of the MDR.
What do the GSPRs cover?
The General Safety and Performance Requirements correspond to a “catalog of requirements” for essential criteria that a medical device must at a minimum fulfill.
The GSPRs / GruSuLa’s cover, among other things:
- all possible, specific requirements of the Risk Management Dossier
- the actual performance data, clinical studies, or clinical evialuations
- chemical, physical, and biological properties
- cleanliness, sterility and infection/microbial contamination prevention
- aspects related to components of possible biological origin
- combinations of measurement functions and compatibility
- radiation issues (intended and unintended)
- Software and medical apps, including programmable medical electrical systems
- Implantable devices such as pacemakers; heat generation; puncture injuries that may occur (e.g., from syringes)
- Further details regarding product labeling and the content of instructions for use (also referred to as “IFU” or “instructions for use”) are required
Demonstration of compliance with the General Safety and Performance Requirements (GSPR) also includes the clinical evaluation (generally, the clinical benefit).
The GSPR are essential to the conformity assessment procedure, apply to all risk classes (I, IIa, IIb, and III), and are highly technical in nature. Ultimately, the focus is on patient safety and product effectiveness.
EU MDR General Safety and Performance Requirements
To efficiently implement the General Safety and Performance Requirements, we will support you with the following practical steps:
- Research Relevant Standards (Significant Aspects)
Identification of key standards that apply to your specific Medical Device.
- Compile a List of Applicable Standards
We help you create a detailed list of harmonized and relevant standards specific to your product.
- Implementing the Normative Requirements
We provide checklists and guidance to ensure your device meets all normative requirements in individual areas.
- Complying with Requirements – Verification & Testing
Assistance with testing, laboratory contacts, and documentation to confirm compliance.
- Finalize the Checklist for the GSPR
We complete the General Safety & Performance Requirements checklist, including references to all conducted tests and verifications.
We provide assistance in the development of these requirements.
You can download a free sample list (GruSuLa checklist) at this link: ‘Basic Safety and Performance Requirements‘.
GSPR • Essential Safety and Performance Requirements
Proof of GSPR compliance is what stands between your device and the CE Mark.
WQS prepares the complete GSPR documentation for all risk classes, with direct access to EU regulatory expertise from our German roots. More than 30 years of MDR experience go into every submission.
Frequently Asked Questions
What are the General Safety & Performance Requirements (GSPRs)?
GSPRs are a comprehensive set of requirements outlined in Annex I of the MDR that ensure Medical Devices are safe, effective, and meet quality standards before being placed on the European market.
Which devices must comply with GSPRs?
All Medical Devices, regardless of class (I, IIa, IIb, III), must comply with General Safety & Performance Requirements. This includes everything from simple bandages to complex implantable devices and medical software.
Where are the legal foundations of the GSPRs defined?
The legal framework for General Safety Performance Requirements is established in Articles 5 and 10 of the MDR, supported by the detailed checklist in Annex I.
How is compliance with the GSPRs verified?
Compliance with GSPRs is demonstrated through a combination of documentation, testing and clinical evidence, culminating in the CE Mark, which indicates that the device meets all regulatory requirements.
What aspects do GSPRs cover?
General Safety Performance Requirements address a wide range of topics, including risk management, clinical evaluation, sterilization, materials of biological origin, software safety, radiation protection, metrology, labeling, and instructions for use.
Why are GSPRs critical for Medical Device manufacturers?
GSPRs form the backbone of the conformity assessment process. Without meeting them, manufacturers cannot legally market their devices in the EU, making them essential for regulatory compliance and market access.
Do GSPRs apply to Medical Software?
Yes, GSPRs include specific requirements for software, especially programmable medical systems and medical apps, ensuring their safety, reliability, and performance under normal conditions of use.
References
- European Parliament & Council of the EU: Regulation (EU) 2017/745 on Medical Devices (MDR), Official Journal of the European Union, May 5, 2017 – eur-lex.europa.eu
- European Parliament & Council of the EU: Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) – eur-lex.europa.eu
