Certification of in vitro diagnostic (IVD) medical devices in the European Union is a key process to ensure that these products are safe and effective for diagnostic applications. Regulation IVDR 2017/746, which came into force on 26 May 2022, introduces significant changes compared to the previous IVD 98/79/EC, placing greater emphasis on protecting public health and improving diagnostic quality. Below are the highlights of the certification process under IVDR 2017/746.
IVDR Regulation 2017/746
Regulation IVDR 2017/746 is the legislation that regulates the marketing of in vitro diagnostic devices in the European Union. It aims to ensure a high level of health and safety for patients and users and to harmonise IVD regulations across the Union. The regulation introduces new conformity assessment requirements that aim to raise the quality and safety standards of IVD devices.
Key requirements of IVDR 2017/746
The key requirements of IVDR 2017/746 include product classification, technical documentation requirements, conformity assessment and Post-market Surveillance (PMS) systems. The introduction of these principles aims to ensure that IVD products are not only effective, but also safe for users.
Classification of IVD devices
The classification of IVD devices according to IVDR 2017/746 is based on the level of risk the device poses to the patient. Devices are classified into one of four classes: A, B, C and D. Class A covers devices with the lowest risk, such as sample containers. Class B refers to devices with medium risk, such as biochemical tests. Class C refers to higher-risk devices, while Class D covers the most dangerous tests, such as those used in cancer diagnostics. The classification of a device is crucial as it affects the conformity assessment requirements and verification procedures.
The IVD conformity assessment process for devices varies depending on their classification. For Class A devices, manufacturers can carry out the conformity assessment themselves by preparing the relevant technical documentation. For Class B, C and D devices, it is necessary to involve a notified body, which reviews the dossier, audits and, for some devices, also clinical evaluation. This approach aims to ensure that the devices meet the IVDR’s quality and safety requirements.
IVD Technical Documentation
The IVD technical documentation, which includes, among other things, risk analysis, clinical data and evidence of compliance with IVDR requirements, should be provided by the manufacturer. This documentation is a key element of the conformity assessment process and should include information on the intended use of the device, results of preclinical and clinical studies, as well as descriptions of the manufacturing and quality control processes. An example would be a clinical study report that provides evidence of the efficacy and safety of a diagnostic test.
Post-market Surveillance (PMS)
Post-market surveillance (PMS) is the process of continuous monitoring of IVD devices after they have been placed on the market. Manufacturers are required to collect data on the safety and efficacy of devices, analyse incident reports and update risk assessments. For example, a manufacturer of an infectious disease diagnostic test may regularly review test result and incident data to ensure compliance with IVDR requirements and take action if problems are detected.
Identification and traceability of IVD devices
Each IVD product must be marked with a unique identifier (UDI), which facilitates its traceability throughout the supply chain. The UDI consists of a unique identification number, manufacturer information and production lot details. With the UDI system, it is possible to quickly identify a device in the event of an incident being reported, which significantly increases safety in use.
Certification process for in vitro diagnostic (IVD) medical devices
The certification process according to IVDR 2017/746 requires diligence and cooperation between the manufacturer and the notified body. It begins with the manufacturer’s notification and provision of a complete technical dossier. The notified body carries out a detailed verification of the dossier and an audit of the production process, leading to the issuing of a certificate of conformity. Our notified body offers comprehensive support to manufacturers at every stage of this process, including certification services, technical dossier review and audits.
Certification of in vitro diagnostic medical devices according to IVDR 2017/746 is a complex process to ensure that devices are safe and effective for diagnosis. Every step, from classification to technical documentation to post-market surveillance, is crucial to maintaining high quality standards. Our Notified Body is ready to support manufacturers in every phase of this process, helping them to comply with the IVDR and bring their products to the European Union market.
