The medical device and in vitro diagnostic (IVD) industries are closely regulated industries, ensuring approval, safety proof and efficiency of products before they appear in the market. These technical file requirements, regulations and evaluations have many intricacies that manufacturers must understand. This article walks you through some of those critical elements which include Medical Device and IVD Technical Files, Clinical and Performance Evaluations, General Safety and Performance Requirements (GSPR), CE marking role of I3CGLOBAL Consultants.
Technical File for Medical Device/IVD
A technical file is a complete file that manufacturers of Medical Devices as well as IVD must prepare to show that the devices comply with the regulatory requirements in the country. The technical file for medical devices consists of device descriptions, design and manufacturing processes, risk management files, clinical evaluations, and labelling. The technical file should include the same things as for M&D and additional data on performance evaluation and validation studies for IVDs. An important role of the technical file is to serve as evidence that the product meets the requisite safety and performance standards, which is a prerequisite to getting the CE marking and thus accessing the EU market.
MDR and IVDR Regulations
The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are not only key for guaranteeing patient safety and performance of medical devices and IVDs in the European Union. MDR- The purpose of the new Medical Device Regulation is to increase the safety and quality of medical devices and MDR has now replaced MDD- Medical Device Directive. It establishes further requirements for clinical evaluations, post-market surveillance, and quality management systems. The IVDR (replacing the In Vitro Diagnostic Directive – IVDD) also places tough obligations on IVDs to ensure that their products are adequately assessed for performance and controlled for risk and that they are subject to ongoing post-market surveillance. Any manufacturer wanting to sell in the EU must know and comply with both or they will not be able to legally sell their products.
Medical Device Clinical Evaluation
Clinical Evaluationis a key element of CE marking a medical device. This is the process of examination of clinical data and evaluation of clinical data to ensure the device is safe and effective. This is an evolving process which needs to be maintained throughout the life of the device. For clinical evaluations, clinical investigations, scientific literature and post-market clinical follow-up (PMCF) are collected which is relevant. MDR requires the performance of thorough clinical assessment from manufacturers, asserting that their devices deliver results as expected and do not pose any risk to patients. This process is in place to make certain that the medical devices not only do what they are supposed to do but are also safe to be used in a clinical setting.
IVD Performance evaluation
It’s just as important for IVDs to be performance evaluation is a complete determination of whether the IVD measures what it is intended to measure, accurately, reliably and repeatably. Performance evaluation Analytic performance, Clinical performance, Scientific validity Similar to the examination of analytical performance is the evaluation of clinical performance, which examines the efficacy of the device when used in a clinical setting. Valid affirms that the analyte measured is associated with a condition or state that clinicians care about. The IVDR highlights the significance of rigorous performance evaluations to ensure IVD performance meets certain expectations required for medical decision-making.
General Safety and Performance Requirements (GSPR)
They are the cornerstone of MDR and IVDR and are detailed in the Basic Requirements that medical devices and IVDs are required to meet to protect health and ensure performance. GSPR relates to device design, manufacturing, labelling, and risk management. In confused terms, you must comply with GSPR to have the CE marking of your product. Before a product can be sold in the EU and the UK, the manufacturer must have complied with the essential requirements and shown this through full technical documentation. GSPR is a set of legislations meant to guarantee that devices are designed and produced to be of high quality, with no risks to patients or users.
Consultants and their Role in CE Marking
For manufacturers, this means figuring out how to handle the complex regulatory landscape. The crucial role of I3CGLOBAL Consultants comes into play at this stage. The company provides dedicated assistance and support during the CE marking route, meeting the requirements of MDR and IVDR. These services revolve around technical file writing, clinical and performance evaluations, and ensuring that compliance with the GSPR requirements is demonstrated. Manufacturers can leverage the resources of their expert-subject providers to complete the necessary steps and get their products to market quickly.
The medical device and IVD industries are tightly regulated, and these regulations are put in place to ensure that the products are safe and effective. Manufacturers need to be aware of these regulations and act according to them, from technical files to performance reviews. With the support of our I3CGLOBAL Consultants, you can successfully obtain CE marking and enter the market quickly and easily without any kind of hassle.
