Artificial intelligence in medicine
More and more medical devices are using artificial intelligence e.g., to diagnose patients more precisely and to treat them more effectively.
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”.
Content
On this page, you will find references to relevant articles.
- Examples of General Safety and Performance Requirements
- Proof of the General Safety and Performance Requirements
- Differences between the requirements of the MDR and the MDD
- Support in demonstrating these 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
Note
The GSPR do not depend on the class of the medical device.
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.
Tip
As a manufacturer, you must demonstrate conformity precisely and sentence by sentence. You can benefit from our checklists such as the MDR checklist.
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
5. Support
Do you still have questions about the basic requirements for medical devices? Then, benefit from free micro-consulting.
The Johner Institute supports medical device manufacturers,
- to prove the requirements with lean technical documentation,
- to check this evidence before the review by a notified body to avoid problems with “approval,”
- prepare the QM system for audits.
Contact us! The Johner Institut team will be happy to assist you!
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