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:
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.
To efficiently implement the General Safety and Performance Requirements, we will support you with the following practical steps:
Identification of key standards that apply to your specific Medical Device.
We help you create a detailed list of harmonized and relevant standards specific to your product.
We provide checklists and guidance to ensure your device meets all normative requirements in individual areas.
Assistance with testing, laboratory contacts, and documentation to confirm compliance.
We complete the General Safety & Performance Requirements checklist, including references to all conducted tests and verifications.
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.
All Medical Devices, regardless of class (I, IIa, IIb, III), must comply with GSPRs. This includes everything from simple bandages to complex implantable devices and medical software.
The legal framework for GSPRs is established in Articles 5 and 10 of the MDR, supported by the detailed checklist in Annex I.
Compliance 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.
GSPRs 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.
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.
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.
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Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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