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Challenges with Transitioning to the EU In Vitro Diagnostic Devices Regulation
The application date of May 26, 2022 for the EU In Vitro Diagnostic Medical Devices Regulation (2017/746), commonly referred to as IVDR, is fast approaching and has created challenges for in vitro diagnostic (IVD) medical device firms planning to introduce or continue to market their products to the European Union member states.
Device Classifications
One of the biggest changes from the in vitro diagnostic directives (IVDD) to IVDR is the move from list-based IVD device classifications to a rule-based IVD medical device classification, resulting in four new device classes: class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body (NB) involvement.
This change requires a large number of NBs, and the increased workload is cause for concern. It is estimated that the quantity of medical device products will increase from 20% under the Medical Devices Directive (MDD) to approximately 80% under IVDR. As of this writing, there are only four IVDR designated NBs, which highlights the shortage.
Scheduling Delays
Proactive strategic planning and effective resource allocation are critical for the timely execution and implementation of a comprehensive IVDR implementation plan. IVDR manufacturers must consider and prepare for potential delays such as scheduling bottlenecks for NB conformity assessment activities, which may directly or indirectly impact their planned commercialization efforts for existing and/or new IVDR products. It is necessary for IVDR manufacturers to establish contingency plans to mitigate some of these potential challenges in this new regulatory environment.
Additional nuances from IVDD to IVDR are based on a medical device life cycle approach and include:
- Requirements for medical device manufacturers to establish and demonstrate effective quality management systems (QMS).
- More stringent requirements for clinical evidence demonstrating conformity.
- New requirements for postmarket performance monitoring and reporting.
- Greater supply chain oversight and device traceability, including giving NBs discretionary authority to monitor supplier audits and subcontractor compliance.
Timing
The move from IVDD to IVDR can be a time-consuming process, and many companies are still in the process of making the transition.
Timing is an issue because companies need to:
- Evaluate if their current NB is still the right partner to work with.
- Plan the regulatory strategy of the current medical device in the field.
- Know the IVDD certificate expiration date and prioritize the products that need immediate attention.
- Classify devices according to the new IVDR classification rules.
No matter the size of your company, if you have not already started your transition, you will need to start preparing for the IVDR deadline now as it is quickly approaching.
Timely compliance to IVDR requires a dedicated team of subject matter experts to properly implement and execute the deliverables as laid out in your IVDR implementation plan. These deliverables may require extensive updates to a manufacturer’s existing QMS, technical documentation, and/or establishing or enhancing a manufacturer’s body of objective evidence of clinical performance validation with a defined blueprint to address the product life cycle.
Having the Proper Team of Experts
Organizations have a better chance of a successful transition by having a dedicated team of subject matter experts who have an intimate familiarity with the planning and implementation of IVDR.
The subject matter experts should identify the intended purpose and inherent risks associated with your device(s), determine the device classification, and help create technical documentation in compliance with IVDR.
Robust procedures for postmarket surveillance and postmarket performance follow-up must be put in place to successfully transition to IVDR.
Conclusion
If you are planning to introduce or continue to market your IVD products to any of the EU member states you must identify the new classifications your devices fall under, anticipate potential scheduling delays caused by the limited number of NBs capable of reviewing IVD device classifications, and plan carefully for the entire process. Putting together the right team to handle the work can ease the transition.
Lisa Michels leads Regulatory Compliance Associates’ growing regulatory department. She is a corporate executive and attorney with more than 18 years’ experience institutionalizing global regulatory compliance in highly regulated markets.
Michels possesses extensive subject matter and technical expertise in the areas of global regulatory strategy and submissions, FDA crisis consulting related to Form 483s and warning letters, and QMS implementation and/or improvement for the medical device and pharmaceutical industries.
She directs the initial and ongoing response strategies for FDA actions, including the development and implementation of robust work plans for quality system remediation and improvement initiatives, and provides third-party oversight for quality and regulatory remediation activity.
Seyed Khorashahi is Executive VP of Medical Devices and Chief Technical Officer (CTO) for Regulatory Compliance Associates Inc. (RCA). He has more than 25 years of experience leading R&D teams in all aspects of developing safety-critical medical devices. Khorashahi held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy.
Khorashahi has significant domain expertise in U.S. Food and Drug Administration (FDA) and EU standards, as well as in software systems and hardware development for medical devices.
