- 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.
EU IVD Regulation
EU IVD Regulation – It is important to understand the difference between a medical device and an in-vitro diagnostic medical device (IVD). IVDs are generally not in direct contact with the human body and do not have any therapeutic effect compared with a medical device. IVDs are basically reagents, reagent products, instruments, software or system and systems, as intended by the manufacturer, used to diagnose a disease or other conditions.
- EU IVD CE Marking means that the particular IVD meets the European regulations, and it is permutable to market in the European Union. At present, the IVD Directive 98/79/EC is0 applicable, and from 26 May 2022 onwards, EU IVDR 2017/746 shall apply.
- The devices categorized as IVD require CE marking as per the IVD Directive 98/79/EC. The involvement of Notified Bodies limited to the devices listed in Annex II of the directive. Most of the devices, at present, are supplying to Europe based on the self-declaration of the manufacturer.
- The manufacturer must ensure that the IVD meets the Essential Requirements of Annex I of IVDD. There must be technical documentation for IVD, irrespective of classification, which demonstrates compliance with applied harmonized standards and applicable Essential Requirements as per IVDD.
New EU IVD Regulation (IVDR 2017/746)
- The new legislation of EU, the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 came into effect in May 2017 and shall apply from 26 May 2022 onwards by replacing the IVDD 98/79/EC. The IVDR comes with an extension of scope in different aspects compared to the present IVDD.
- As per EU IVDR, the IVDs are classified under four different classes, A, B, C and D, based on the risk associated with the device. As per this new classification, more than 80% of IVDs will require CE certification with the involvement of Notified Bodies.
- The IVDR comes with many requirements to ensure that the IVDs marketed in the EU must meet compliance with all aspects. It provides guidelines to economic operators, comes with a specific structure for technical file, the appointment of PRRC, and most importantly, the UDI.
EU IVD CE Marking Consultants
- At present, nearly 20 % of IVDs requires Notified Body involvement as per IVDD; however, once EU IVDR comes into action, more than 80% of IVDs will require Notified Body scrutiny to get the CE mark. It means the manufacturers have to upgrade their files as per EU IVDR requirements.
- Preparation of PE plan, PMPF If the manufacturer does not have a team of experienced QMS & RA professionals, then EU IVDR transition is exceedingly difficult for them. They must hire experts or consultants who are having good experience in this field.
- IVDR Consultants or experts can support the organization by doing the gap analysis, which includes the classification of the device as per EU IVDR, review of technical data, provide guidance and make strategies to meet the requirements and also supports all the way to get the CE mark by communicating with Notified Body in every aspect.
Additional Information about new EU IVDR 2017/745
IVDR Classification
IVDR Technical Documentation / Technical File
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.
Notified Body Review and approval Process
- 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 – An overview
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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