General Safety and Performance Requirements (GSPR)

The EU medical device regulations (MDR and IVDR) refer to the requirements that every medical device must meet as General Safety and Performance Requirements (GSPR).

The previous Medical Device Directive (MDD) referred to the “general requirements”.

1. Examples of General Safety and Performance Requirements

The MDR and IVDR list the General Safety and Performance Requirements in their respective Annexes I. Examples of GSPR are:

• Risk management that ensures an acceptable benefit-risk ratio
• Performance of the devices, especially in terms of essential performance
• Electrical safety
• Mechanical safety
• Functional safety for medical devices
• Biological safety, e.g., biocompatibility
• IT security
• Software life-cycle processes, including verification and validation
• Usability
• Instructions for use

2. Proof of the general requirements

The manufacturers themselves provide proof that the medical devices meet these general requirements as part of a conformity assessment procedure. Depending on this conformity assessment procedure, they have to involve notified bodies.

Manufacturers often use harmonized standards to prove conformity with the General Safety and Performance Requirements.

The MDR and IVDR also require compliance with so-called common specifications.

3. Differences between MDD and MDR

The MDR and IVDR formulate the requirements more granularly than the MDD respectively the IVD did and have expanded them. In addition, the MDR and IVDR distinguish between the “General Safety and Performance Requirements” (Annex I) and the requirements and their verification in the technical documentation (Annex II).

Compared to the MDD, the MDR also explicitly sets out requirements for:

• IT security
• Devices containing medicinal products
• Devices containing tissues of human or animal origin
• Disposal
• Active implantable devices (which were not in the scope of the MDD)
• Devices intended to be used by lay persons
• Labeling