In-Vitro-Diagnostics

Performance Evaluation Report (PER) / Performance Evaluation Plan (PEP)

Manufacturers of in vitro diagnostics are required to evaluate performance and safety of their products and validate the diagnostic performance as part of the technical documentation. For this purpose, the diagnostic performance and sensitivity of the product need to be tested in an analytical, and usually also a clinical study, which are documented in a Performance Evaluation Report (PER). This report needs to be updated continually. 
The regulatory demands for diagnostic products have increased significantly since Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation, IVDR) became generally applicable on 26 May 2022. This creates new challenges for the manufacturers, especially if the diagnostic products are already on the market.

The Performance Evaluation Report for in vitro diagnostics (IVDs) is composed of three parts:

  1. The scientific background of the diagnostic method including the reasoning for choosing that specific method and its scientific validity
  2. Validation of the analytical performance of the diagnostic product 
  3. Validation of the clinical performance of the diagnostic product

Based on the data of the PER, a benefit-risk analysis needs to be established which demonstrates the acceptability of all risks compared to the benefits. The risks and hazards that may be posed by the use of the product (for the patient, but also for the user) need to be evaluated in a hazard analysis. Subsequently, conformity with all relevant General Safety and Performance Requirements (GSPRs), as specified in Annex I of the IVDR, must be demonstrated.

Dr. Ebeling & Assoc. GmbH will be happy to support you in the preparation of the Performance Evaluation Report according to the current IVDR and the MDCG guidances for a successful validation by your Notified Body. Please send your inquiry to the following address: medicaldevice@ebeling-assoc.com