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”.
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On this page, you will find references to relevant articles.
The MDR and IVDR list the General Safety and Performance Requirements in their respective Annexes I. Examples of GSPR are:
The GSPR do not depend on the class of the medical device.
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.
As a manufacturer, you must demonstrate conformity precisely and sentence by sentence. You can benefit from our checklists such as the MDR checklist.
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:
Do you still have questions about the basic requirements for medical devices? Then, benefit from free micro-consulting.
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