In an advancing medical field, in vitro diagnostic medical devices aid in diagnosing, preventing, monitoring, and treating various diseases. As the variety and complexity of these devices grow, so does the need for comprehensive regulations. The European Union (EU) has established a regulatory framework to ensure the safety and effectiveness of all medical devices available in its market.
While Regulation (EU) 2017/745 governs medical devices, the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, or IVDR, was introduced to enhance the regulatory standards for in vitro diagnostic devices. This was in response to the evolving technology in medical devices and to address gaps in the previous system.
For non-EU regulators, the EU IVDR means significant regulatory documentation and labelling changes. This article will provide an overview of the Regulation and its implications for non-EU regulators.
About the IVD Regulation (EU) 2017/746
Introduced on 5 May 2017, the IVD Regulation (EU) 2017/746 was set to replace the preceding In Vitro Diagnostic Medical Devices Directive (IVDD). Unlike the IVDD, which required individual EU member states to transpose its provisions into national law, this new Regulation is automatically enforceable. This approach was designed to ensure uniformity and reduce potential discrepancies in interpretation across the EU.
In May 2022, after a designated five-year transition period, over 31,000 in vitro diagnostic medical devices (IVDs) should have complied with this Regulation’s requirements.
The IVDR introduces an array of provisions that cover everything from performance evaluations and studies to the market introduction and ongoing surveillance of IVDs within the EU. A notable feature is its updated medical devices classification system, harmonised with international standards.
Additionally, the IVDR places most IVDs under the oversight of a notified body review, emphasising rigorous safety and performance standards. However, given the diverse nature of IVDs, these adjustments will vary based on the specifics of each product.
Purpose of the IVD Regulation (EU) 2017/746
Legal considerations
The primary objective of the IVD Regulation (EU) 2017/746 is to modernise and enhance the guidelines governing IVD medical devices and their accessories within the EU market. Specifically, the Regulation:
- Standardises the procedures for introducing, distributing, and operating IVD medical devices and their accessories in the EU;
- Establishes guidelines for conducting performance evaluations of IVD devices and their associated tools; and
- Prioritises patient safety by implementing stricter conformity assessment protocols.
This way, only compliant and safe devices reach consumers and enhance post-market surveillance. The combined effects of these measures are designed to foster an environment of trust and safety for IVD manufacturers and end-users in the EU.
Adjusted Transition Periods for IVD Devices
During the COVID-19 pandemic, unexpected challenges made it necessary to adjust the transition periods of the IVD Regulation (EU) 2017/746. Consequently, Regulation (EU) 2022/112 was introduced, amending and extending some of these periods based on the risk classification of the devices:
High-risk devices (Class D and C)
- HIV or hepatitis tests (Class D): Extended transition period until 26 May 2025
- Certain influenza tests (Class C): Extended transition period until 26 May 2026
Lower-risk devices
- Class B and Class A – sterile: The transition period concludes on 26 May 2027
In-house devices
- Devices manufactured and used within the same health institutions: Extended transition period until May 2024.
The stipulation requiring a justification that an equivalent market device cannot meet patient needs will take effect from May 2028. As a result, medical device manufacturers will have adequate time to comply with the medical device regulations while accommodating ongoing pandemic-related health challenges.
EU IVDR’s Implications and Recommendations for Non-EU Regulatory Bodies
The introduction of the EU IVDR will have varying implications across jurisdictions due to diverse local product registration requirements.
Typically, changes that don’t impact the safety or performance of a device are viewed as ‘non-significant’ or ‘minor.’ Conversely, alterations impacting a device’s safety or performance are deemed ‘significant.’ Here are some factors that non-EU regulators must consider:
Manufacturers must assess how EU IVDR-related changes impact their products. If changes due to EU IVDR don’t alter the device’s safety or performance, they are typically deemed non-significant.
Instructions for use (IFU) adjustments
Revisions to the IFU, especially the intended purpose section, require thorough analysis. Any alteration to the intended purpose due to EU IVDR’s evidence needs—and not device concerns—calls for in-depth review and correct categorisation by manufacturers.
Reporting obligations
Different regions have varying requirements for reporting changes. Considering the likely surge in notifications because of the EU IVDR, regulators should adopt a strategic approach to handle these without disrupting supply chains.
Final recommendations for regulators
To streamline the transition, regulatory authorities should devise practical strategies. For instance, generating guidance to simplify notification prerequisites for changes originating from the EU IVDR transition could be invaluable.
Such advisories, possibly temporary and applicable until the complete EU IVDR transition (27 May 2027), would bestow clarity and smoothen the transition process. This would minimise administrative overheads and curtail potential supply interruptions.
Process for IVDR Compliance
To ensure adherence to the IVDR, manufacturers must undertake the following steps:
- European representation: Appoint a European-authorised representative.
- Legislative identification: Recognise all EU Directives and Regulations relevant to your product, such as IVDR, WEEE, and EMC.
- Conformity assessment: Choose and execute the appropriate conformity assessment procedure for your product.
- Safety and performance check: Evaluate your device against the General Safety and Performance Requirements.
- Harmonised standards: Determine the pertinent harmonised standards for your product.
- Technical file and QMS: Compile a technical file and institute a Quality Management System (QMS).
- Engage a notified body: For all except Class A devices, select a Notified Body and finalise your Declaration of Conformity.
Bottom Line
The transition to the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) represents a significant stride in aligning EU legislation with the evolving landscape of technical advances and shifts in medical science. Beyond keeping pace with the times, the IVDR lays a foundation for a robust, transparent, and sustainable regulatory framework.
This internationally recognised framework underscores the importance of clinical safety while ensuring a level playing field for manufacturers. To ensure continued compliance and, more importantly, safe and effective diagnostic solutions for patients in the European Union and beyond, international medical device manufacturers will need to understand the intricacies of the IVDR.
Seek Expert Guidance on Navigating the EU IVDR Landscape
If you seek guidance in understanding and ensuring compliance with the IVDR, Vicki Partridge is the expert you need. With her deep-rooted experience in biological research, medical devices, and with the Therapeutic Goods Administration (TGA), Vicki has established a sterling reputation in delivering high-calibre medical device regulatory consulting services to clients spanning the United States, Europe, Asia, and Australia.
To learn more about how Vicki can assist you in navigating the EU IVDR landscape, contact her office at +61 7 55295508 or email vicki@vickipartridge.com.au.