The Performance Evaluation is a crucial element of a device’s conformity with the general safety and performance requirements (GSPR) of Annex I of the EU IVD medical device Regulation 2017/746 (IVDR), which should take into account the device’s normal conditions of its intended use and evaluate of the interference and cross-reaction and of the acceptability of the benefit-risk ratio (as referred to in Sections 1 and 8 of Annex I). In general, the basis and requirements for the Clinical Evaluation are laid down in Article 56 and Annex XIII of the IVDR.
The Performance Evaluation shall be planned in accordance with the requirements of Annex XII Part A and be recorded within a Performance Evaluation Plan (PEP). Manufacturers should also have in place an updated Performance Evaluation Procedure, as part of their Quality Management System (QMS), which shall provide an indication for the need of a PEP in order to comply with the IVDR, as part of their technical documentation. The PEP shall take into account the intended purpose of the device, the analyte or marker to be determined by the device, description of the indications, limitations and contraindications, and shall provide a plan for the Post-Market Performance Follow-up (PMPF).
Once these activities are performed, they shall be reported and analysed within the device’s Performance Evaluation Report (PER), which is arguably the most important document within the IVDR technical documentation and which summarises and presents data collected to substantiate claims of scientific validity, clinical and analytical performance.
All devices, even low-risk IVDs, must have a Performance Evaluation Plan and Report in place. The complexity of these documents will vary greatly depending on device risk, device type, and novelty. For higher risk IVDs, one would expect a greater collection and analysis of relevant data, preferably obtained through performance evaluations.
An understanding of Article 61, Annex XIV, as well as relevant MEDDEV and MDCG guidance documents will be paramount in meeting the requirements of the Clinical Evaluation and thus getting your product to market.
Advena specialises in the creation of Performance Evaluation Plans and Reports for all device types, utilising our team of in-house and experienced consultants. The documents we create for you are state-of-the-art and are continuously being updated to reflect changes in interpretation, best-practice, and Notified Body expectations. Furthermore, you may wish to contract Advena to review your Performance Evaluation prior to submission to a NB. Our review will highlight any deficiencies and also provide guidance in closing these gaps, all within one report.
For more information, please contact the Advena team:
