The specifics for medical devices refer to a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This includes the type of medical conditions the device is designed to diagnose, treat, monitor, alleviate, or prevent.
A Performance Evaluation Report (PER) is a comprehensive clinical document that demonstrates the safety and performance of In Vitro Diagnostic (IVD) devices. It is mandatory for manufacturers to submit this document to place their IVDs in the European Union (EU) market. The PER is built on the foundation of the following three (03) pillars of data demonstration:
As we all know, to place an In Vitro Diagnostic (IVD) device in the European Union (EU) market, manufacturers must abide by the EU IVD Regulations (EU IVDR) 2017/746. One of the key requirements of the IVDR cycle is performance evaluation. The objective of performance evaluation is to demonstrate that the IVD is safe and effective to use, and at the same time, it is aligned with its intended use. The performance evaluation of in the IVD begins with the devising of a Performance Evaluation Plan (PEP).
CE marking is mandatory for all devices that are to be sold in the European Union (EU) countries. Similarly, In Vitro Diagnostic (IVD) devices must also obtain a CE marking and undergo a rigorous approval process to demonstrate their safety and efficacy. They have to abide by the requirements mentioned under the EU In Vitro Diagnostic Device Regulation (IVDR) 2017/746. Each device has a specific set of requirements and procedures that they need to follow. In fact, the Regulatory requirements can be complex and challenging to follow.
With the implementation of the European Union (EU) Medical Device Regulation (MDR) 2017/745, one of the areas that caught the most attention was the new Post-Market Surveillance (PMS) system for devices. Establishing a PMS for a device has become a mandatory task for manufacturers. The objective behind this stringent requirement is to ensure device safety throughout the product’s lifecycle. Post-market Clinical Follow-up (PMCF) is part of the PMS and refers to the evaluation and collection of data for the devices placed in the market.
With the implementation of the European Union (EU) In Vitro Diagnostic Devices Regulations (IVDR) 2017/746, the Performance Evaluation Report (PER) has changed dynamically in terms of its requirements and approach.
Medical device manufacturers must complete the Gulf Cooperation Council (GCC) medical device registration process to sell their products in Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). The registration procedure ensures that the medical devices sold in these countries adhere to the essential quality and safety requirements as well as the relevant regulations. The registration procedures in the GCC nations may differ from one country to another.
The development of In-Vitro Diagnostic (IVD) devices is a classic example in the healthcare sector, where modern technology has enabled healthcare professionals to improve treatment regimes for serious life-threatening health conditions. While Regulatory agencies worldwide are working towards harmonized regulations to market IVDs, China’s NMPA has led to stringent guidelines for the regulation of IVDs in China market.
The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR).
A Scientific Validity Report (SVR) is a part of the Performance Evaluation Report (PER) under the European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 that documents the scientific validation of the IVDs. The SVR supports the device's conformity assessment and for the same one must consider any relevant published literature and standards. It is usually accompanied by a summary of the results of the assessment.
