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) 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.

The legal foundation for these requirements is established in Articles 5 and 10 of the MDR, which define the general obligations for manufacturers.

These General Safety and Performance Requirements (formerly “General Requirements”) form a comprehensive checklist of critical safety, quality, and performance criteria that every medical device must meet. These requirements cover:

Risk Management
Clinical Evidence with the actual Performance Data
Chemical, physica and biological properties
Cleanliness, sterility and infection/microbial contamination prevention
Materials of biological origin
Device combinations and compatibility
Measurement accuracy and metrology
Radiation protection (both intended and unintended exposure)
Software and medical apps, including programmable medical electrical systems
Implantable devices such as pacemakers, heat generation, needlestick injuries that may occur (e.g. when injecting)
Comprehensive labeling and instructions for use (IFU) requirements

Proof of compliance with the General Safety and Performance Requirements is provided by the CE Mark.

The GSPRs are critical for all risk classes (I, IIa, IIb, and III) and form the backbone of the conformity assessment process. Their complexity reflects the high safety and performance standards required in the EU – ultimately ensuring 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‘.

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

General Safety & Performance Requirements (GSPRs)

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.

This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.