- As per EU IVDR, the devices are classified A, B, C and D, based on the intended purpose and inherent risks. The conformity assessment route and post-market requirements mainly depend on the classification of the device. The classification of a particular device is carried out as per Annex VIII of EU IVDR.
- For Class A devices, the manufacturer can declare conformity by issuing the EU declaration of conformity after making the technical file as per EU IVDR. For Class B, C and D devices, the conformity assessment will be done by notified bodies.
- Class D consists of high-risk devices and covers the blood grouping devices; the examples are the devices intended for Hepatitis B, C and D, HIV 1 and 2, ABO System, Rhesus. Class C covers a mix of devices, such as companion diagnostics, some self-testing IVDs and devices, which have less risk to the wider population.
- Class B covers a greater number of devices with less risk than Class C & D. Self-testing devices for pregnancy and fertility testing, devices intended for detection of Influenza A/B virus, which is a non-pandemic, are some of the examples for Class B devices.
All In Vitro Diagnostic Devices manufacturers require a technical file as per the Annex II and Annex III of EU IVDR. Technical files of Class B, C and D devices will be reviewed by the Notified Body, whereas for Class A device, there is no review by Notified Body; however, the manufacturer must have a technical file and keep up to date the regulations.
The technical file of an IVD mainly includes technical data, performance evaluation and post-market surveillance details. Technical data includes device description, intended purpose, comparison with similar devices, risk-benefit analysis, etc. Performance evaluation of IVD includes scientific validity, analytical performance and clinical performance reports. The PMS plan covers the effective and appropriate methods and processes for collecting the data.
Requirements to be full filled by manufacturers in completing a technical File
- It is an uphill task for the manufacturers to meet the EU IVDR requirements for technical file preparation. They have to identify the device classifications and perform a gap analysis by comparing the existing files against the requirements. Then the manufacturers must plan for each and every requirement that need to be fulfilled for their particular devices.
- The manufacturers must prioritise the performance evaluation as it will take time to plan, collect, and analyze the data. And also for the risk-benefit analysis, as per the intended use of the device. Those devices, which are not under NB involvement as per IVDD and require NB involvement as per EU IVDR, need much attention.
Role of an expert like you in the successful completion of Technical File
- The technical file is the critical document for a device that needs to have the CE mark, which has to prepare according to the regulations and keep up to date. Consultants with specific expertise in technical file preparation will help the organizations to make the technical files as per the regulations.
- The technical file of an IVD involves many sections. As per the regulation, all the manufacturers must have a technical file, irrespective of their device classification, which involves many sections and contains a large amount of data. The consultant has experience in the IVD technical file can make the file clear, organized, readily searchable, and unambiguous, as mentioned in the Annex II & III of EU IVDR.
- According to the EU IVDR, the notified body has to carry out the conformity activities with the highest degree of professional integrity. The notified bodies must have the required expertise to conduct the conformity assessment effectively.
- The NB reviews the following, as part of their conformity assessment process,
- The technical documentation
- The solutions adopted by the manufacture meet the requirements listed out in Annex I of EU IVDR.
- Design and Development files
- Procedures and documentation related to performance evaluation
- Risk management process
- PMS & PMPF
Performance Evaluation of an In Vitro diagnostic device (IVD) involves assessing and analysing data, which is required to demonstrate the scientific validity, analytical performance, and clinical performance of a device. The performance evaluation conducted by the manufacturer is as per the requirements of Article 56 and Annex XIII of EU IVDR. The performance evaluation considering both favourable and unfavourable data. The depth and extent of the data are proportionate and appropriate to the characteristics of the device, including the risks, risk class, performance and its intended purpose.
Performance evaluation of a device is a continuous process. To plan, conduct and document a performance evaluation, the manufacturer should establish and update a performance evaluation plan, as per EU IVDR. The performance evaluation plan specifies the characteristics and the performance of the device, the process and the criteria applied to generate the necessary clinical evidence of a particular IVD.
How to conduct Performance evaluation
- To conduct a performance evaluation, the manufacturer must have a performance evaluation plan, which includes the following, the specifications of the intended purpose of the device, the characteristics of the device, the analyst or marker to be determined by the device, the intended use of the device, the methods, including the appropriate statistical tools and also the description of state of the art.
- The performance evaluation should be updated throughout the life cycle of the IVD with the data obtained from the implementation of the manufacturer’s PMPF plan in accordance with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79 of EU IVDR. The performance evaluation report for class C and D devices is required to be updated when necessary, but at least annually.
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