The application date of May 26, 2022 for the EU In Vitro Diagnostic Medical Devices Regulation (2017/746), commonly referred to as IVDR, has come and gone. IVDR has created challenges for in vitro diagnostic (IVD) medical device firms planning to introduce or continue to market their products to the European Union.
IVD 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. The new classification results 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. Moreover, 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.
IVD 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. Scheduling bottlenecks for NB conformity assessment activities can impact planned commercialization efforts for existing and/or new IVDR products. It is necessary for IVDR manufacturers to establish contingency plans to mitigate these potential challenges.
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.
The move from IVDD to IVDR can be a time-consuming process, and many medical device 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.
For example, the goal is 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 and technical documentation. Likewise, establishing or enhancing a manufacturer’s body of objective evidence of clinical performance is validation for the product lifecycle.
Having the Proper Team of IVD Experts
Organizations have a better chance of a successful transition by having a team of subject matter experts with intimate familiarity of the implementation of IVDR.
The subject matter experts should identify the intended purpose and inherent risks associated with your device(s). This will 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.
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. This includes anticipating potential scheduling delays caused by the limited number of NBs capable of reviewing IVD device classifications. Above all, plan carefully for the entire process. Putting together the right team to handle the work can ease the transition.
About RCA’s Medical Device Services
The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.
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About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
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