General Safety & Performace Requirements

GruSuLa (General Safety & Performace Requirements)

Every Medical Device that undergoes a conformity assessment procedure in Europe must meet the General Safety and Performance Requirements according to Annex I of the European Medical Device Regulation. It does not matter whether it is an adhesive plaster or a computer tomograph. The legal basis is derived from Articles 5 and 10 (manufacturer obligations) of the MDR.

These General Safety and Performance Requirements (formerly “General Requirements”) correspond to a “Catalogue of Requirements” for essential criteria that a Medical Device must at least fulfill. In doing so, all possible specific requirements are considered, from Risk Management, to the actual performance data and chemical, physical, biological properties, purity requirements to prevent infections and microbial contamination, aspects of components of possible biological origin, combinations, measuring functions, radiation issues (intended and unintentional), medical apps and programmable medical electrical systems, implantable products such as pacemakers, heat generation, needlestick injuries that may occur (e.g. when injecting) and further details on the labeling of the products and the content of instructions for use (including ifu “instruction for use”). Proof of compliance with the General Safety and Performance Requirements is provided by the CE Mark.

The “GruSuLas” are SIGNIFICANT for the conformity assessment procedure, apply to all Risk Classes and, as we see it, have a high intellectual standard. Ultimately, it is about patient safety and the effectiveness of the products.

In terms of practical implementation, we propose the following procedure:

• Research of Standards (Significant Aspects)
• Creating a List of Applicable Standards
• Implementing the Normative Requirements (as Checklists for the Individual Areas)
• Complying with Requirements (e.g. Conducting Tests, Contacting Laboratories, etc.)
• Completing the Checklist for the General Safety and Performance Requirements with References to the Tests Conducted

Please contact us for further and more detailed information. We are happy to offer you a non-binding offer.