Understand the key aspects of the In Vitro Diagnostic Regulation (IVDR), including conformity assessments, performance evaluation, clinical evidence, post-market surveillance, and UDI requirements for IVDD manufacturers.
IVDDs are medical devices that are used to examine specimens taken from the human body (such as blood, urine or tissue) to detect certain substance (such as biomarkers), or to determine the presence of a medical condition. The IVDR replaced the previous In Vitro Diagnostic Directive (IVDD) plurals in IVDDs, which went into effect on May 26, 2017, and places a greater burden on the IVDDs manufacturer to ensure safety and performance.
Conformity Assessment
Under the IVDR, IVDDs manufacturers must go through a conformity assessment procedure to show that their devices satisfy the applicable regulatory requirements. The notified body shall appraise the technical documentation, Performance Evaluation Report (PER), and clinical evidence which is all part of this procedure. Notified Bodies are independent bodies designated by an EU member state to assess the conformity of the devices with IVDR requirements.
PER (Performance Evaluation Report)
The Performance Evaluation Report (PER): This is a detailed report that includes the intended purpose, technical specifications, and performance specifications of the device. It also describes outcomes from analytical and clinical performance evaluation studies of the device. This performance evaluation report (PER) is based on the performance evaluation plan (PEP), which describes the studies that should be conducted to collect the data needed for the PER.
Clinical Evidence
A device’s Safety & Performance claims need to be backed up with Clinical Evidence as required in IVDR. The clinical evidence should derive from clinical performance studies (CPSs) supporting the analytical and/or clinical performance of the device in the intended population. In addition, the manufacturer must also establish clinical validity and clinical utility that the device will ultimately result in improved patient outcomes.
Unique Device Identifier (UDI)
All IVDDs must carry a unique device identifier (UDI) to identify the device and the manufacturer under the IVDR. The UDI needs to be in accordance with the global UDI system and allows tracing the device within its lifetime.
Post-Market Surveillance (PMS)
For example, The IVDR necessitates a post-market surveillance (PMS) system in place by the manufacturer to continuously track the safety and performance of the device after it has been placed on market. A post-market performance follow-up (PMPF) plan should be part of the PMS system in order to capture non-conformities and/or incidents related to the device over a period of time and therefore to identify both potential adverse events, if any, and any safety issues associated with the device performance whenused over time..
GSPR (General Safety and Performance Requirements)
The IVDR brings together GSPRs for all IVDDs. The GSPRs span Risk Management, QMS, Labeling and Instruction for Use (IFU). In short, to get a CE marking for the device, the manufacturer must prove that it complies with the GSPRs.
Conclusion
The IVDR is a key departure from the current IVDDs regulatory landscape applicable to their manufacturers in the EU. Since then, IVDDs must comply more strictly with conformity assessment, performance evaluation and clinical evidence to guarantee their safety as well as their performance. It is imperative that manufacturers understand these requirements and build a robust plan for compliance to ensure their access to the EU market.
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