Guidelines
The IVD Regulation introduces more stringent General Safety and Performance Requirements (GSPRs) in Annex I compared to the Essential Requirements of the previous IVD Directive. While the Directive listed 13 Essential Requirements, the Regulation now specifies 20 requirements that must be addressed.
IVD manufacturers must demonstrate conformity with the GSPRs, including the use of justification, validation, and verification of the solutions used to meet the applicable requirements. For those requirements which are considered to not be applicable, a justification of this fact must be provided.
The completed checklist must include:
- The general safety and performance requirements that apply to the device and an explanation as to why others do not apply;
- The method or methods used to demonstrate conformity with each applicable requirement;
- The standards, common specifications, or other solutions applied to meet the requirement;
- The precise identity of the controlled documents offering evidence of conformity with each standard,
- common specification or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence with the full technical documentation.