21 Mar
Europe’s IVD Regulation
The European Commission (EC) introduced the draft of the European Regulations for In Vitro Diagnostics (IVDs) in 2012. After extensive negotiations between the European Parliament, European Council, and EC, a compromise text was agreed upon. The final regulation was published in 2017 in the Official Journal of the European Union (OJEU) as the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) No. 2017/7461, with a date of application (DoA) set for May 26, 2022.
Evolution from IVDD to IVDR
The IVD Directive (IVDD) 98/79/EC, established in 1998, aimed to ensure the free circulation of IVD devices within the European market. To evaluate the need for updates, public consultations were conducted in 2008 and 2010. It became clear that new technologies, including genetic testing, demanded improved regulatory clarity. Issues related to international alignment and oversight of high-risk in-house tests were also identified. The PIP scandal revealed significant flaws in CE marking certification by notified bodies, prompting the adoption of a code of conduct by many bodies. Nevertheless, the number of active certifying entities continued to decline.
Path to New Legislation
The initial aim during the revision of the Medical Devices Directive (MDD) was to consolidate MDD, Active Implantable Medical Devices Directive (AIMDD), and IVDD into a single regulation. However, the process ultimately resulted in separate legislation for IVDs. In 2012, the EC presented draft regulations for both medical devices (MDR) and IVDs (IVDR). The European Parliament proposed 347 amendments to MDR and 254 amendments to IVDR, to which the European Council responded in 2015. A trilogue negotiation commenced in October 2015 to reconcile differences, culminating in a finalized compromise text in June 2016.
Implementation and Transitional Arrangements
Following the official publication of MDR and IVDR in 2017, the Medical Device Coordination Group (MDCG) introduced numerous implementing regulations and guidance documents. In 2022, Regulation (EU) No. 2022/1126 had a notable impact on IVDR implementation while maintaining the original DoA of May 26, 2022. Self-certified IVD devices reclassified under IVDR, which had already been compliant with IVDD before the DoA, were given additional time to transition. The validity of notified body-issued IVDD CE marking certificates was extended to May 27, 2025. Regulation 2023/6077 eliminated fixed sell-off deadlines.
Key Changes and Themes of the IVDR
The IVDR introduces a comprehensive risk-based classification system, categorizing devices into four classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk). Higher-risk devices necessitate notified body involvement, adding pressure on regulatory resources. The regulation also adopts a life cycle management approach akin to the practices advocated by the US FDA and other international standards. This approach emphasizes performance evaluation and post-market surveillance. Additionally, the regulation enforces stricter qualifications for notified body staff and introduces enhanced supervisory measures.
Organizational Structure and Definitions
The IVDR is systematically organized into 10 chapters and 14 annexes, defining its requirements comprehensively. Chapter I focuses on scope and definitions, increasing from 10 in the IVDD to 74 in the IVDR. Notable new concepts include companion diagnostics, genetic testing, falsified devices, and single-use devices, promoting clarity and consistency in regulatory practices.
Classification and Conformity Assessment
The IVDR categorizes devices based on risk into four classes, ranging from Class A (non-sterile, self-certifying) to Class D (high-risk, requiring batch verification and notified body involvement). Conformity assessment procedures are linked to the risk class, with higher classes requiring more stringent evaluations. This risk-based classification system enhances patient safety and aligns with international guidelines.
Post-Market Surveillance and Vigilance
Post-market surveillance (PMS) ensures continuous monitoring of device safety and performance after being placed on the market. The IVDR mandates manufacturers to implement a PMS plan and submit periodic safety update reports, particularly for higher-risk devices. Vigilance reporting requires documenting incidents and corrective actions within the European Database on Medical Devices (EUDAMED).
Unique Device Identification (UDI) and Databases
The IVDR requires devices to carry a Unique Device Identifier (UDI) to facilitate traceability. The UDI system supports a database that enables authorities and stakeholders to monitor device performance and safety. EUDAMED serves as a centralized platform for tracking devices, performance studies, and vigilance activities, ensuring transparency and access to key data.
Clinical Evidence and Performance Evaluation
Manufacturers must collect and maintain clinical evidence demonstrating the safety and performance of their devices. Performance evaluation is a continuous process involving analytical and clinical performance studies. The regulation specifies the need for scientific validity, ensuring the accuracy and reliability of diagnostic results.
Regulatory Compliance and Liability
Manufacturers are responsible for demonstrating compliance with the IVDR requirements, including risk management and quality assurance. They must also designate a Person Responsible for Regulatory Compliance (PRRC) to oversee adherence to regulations. Liability provisions ensure that patients can claim damages in cases of device failure or harm.
Conclusion
The IVDR marks a significant shift towards stricter oversight and a more structured approach to device classification and post-market monitoring. It introduces rigorous requirements for clinical evidence, performance evaluation, and transparency. While increasing regulatory burdens, it also aims to enhance patient safety and device reliability in the EU market.
Topics: #healthcare #lifeSciences #medicaldevices #medtech #medicaltechnology #MedSysCon #IVD #europe #regulation
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