As we move closer to the May 2022 deadline where all IVD products marketed in the EU must meet the new IVDR regulations, it is imperative for manufacturers to begin the process of implementing the mandated requirements.
To help manufacturers navigate this complex landscape, Karin Hughes, PhD, Senior Vice President, Regulatory & Quality, delivered a presentation during the 14th Annual IVD Clinical & Regulatory Affairs Conference in October, 2020. This webinar, Ensuring Compliance with IVDR Clinical Requirements, covers considerations and best practices across the following topics:
- Developing clinical evidence reflective of a European population
- Establishment of scientific, clinical, & analytical validity
- Implementation of a risk based post market surveillance system
- Confirming the IVD test adheres to “state of the art” definition
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Beaufort can support all facets of your IVDR implementation. Our team of IVDR subject matter experts have an in-depth understanding of the complex details, regulatory expectations and new mandatory requirements. We provide the strategic and technical guidance to develop an appropriate project plan, as well as assist with the implementation of any stage of the IVDR certification process.
Read more about Beaufort’s comprehensive IVDR compliance services. Interested in having a conversation? Email us at [email protected] or submit your request today.
Beaufort CRO was proud to sponsor the 14th Annual IVD Clinical & Regulatory Affairs Conference in October, 2020, and partner with Q1 Productions on this important industry event.
The long-awaited Medical Device Coordination Group (MDCG) Guidance on Clinical Evidence is now available.
The 31-page document, MDC 2022-2, outlines how clinical evidence is to be demonstrated pursuant to the requirements of the IVDR.
What does this mean for study sponsors and manufacturers? In short, the need for continuous oversight of clinical data and performance evaluation throughout the IVD’s entire lifecycle from pre-market release to post-market surveillance and follow-up.
The guidance, which also includes more than 5 pages of definitions, details the specific principles and procedures to follow over the entire lifetime of a product, with dedicated sections across the following areas:
- General principles of Clinical Evidence
- Performance evaluation process
- The role of risk management in performance evaluation
- Performance Evaluation Plan (PEP)
- Scientific Validity, Analytical Performance and Clinical Performance
- Performance Evaluation Report (PER)
- Continuous update of the performance evaluation
The last point on continuous performance evaluation reflects the overarching approach manufacturers must adopt, as stated in the excerpt below:
“Scientific developments and improvements in state-of-the-art should be reviewed and assessed by the manufacturer on a regular basis as part of their continuous and pro-active postmarket surveillance activities. Therefore, manufacturers must instate a procedure for planned monitoring of scientific developments and changes in medical practice relevant to the IVD(s). Any relevant new information, developments and progress in the scientific field should trigger reassessments of the existing clinical evidence thus ensuring safety and performance through a continuous performance evaluation process.”
This guidance document also includes an appendix on the methodological principle for generating clinical evidence as well as the required frequency for updating reports. All of which reinforces the critical need for a systematic approach to short and long-term study planning – and the benefit of having Beaufort’s highly-skilled IVDR team by your side.
Download the Full MDCG 2022-2 Guidance Document
IVD Sponsors and CROs are tasked with identifying new processes and systems to facilitate clinical trial monitoring and management remotely due to COVID-19 restrictions.
This requires developing and implementing plans to continue subject enrollment, sample collection and testing, efficient data collection and monitoring without the benefit of in-person, on-site review. The use of technology and innovation are critical to perform these clinical study tasks remotely and keep projects on track. During this webinar, Beaufort will review a case study that details the required planning and implementation of best practices to conduct monitoring visits remotely, including:
- Factors in the Sponsor/CRO Assessments/Decision-making processes:
- Which sites are equipped to participate in monitoring visits performed remotely?
- Which types of visits can be performed remotely and related key considerations?
- What technologies & processes can be used to remotely review source documents & site binder documents?
- How to effectively communicate with the Principal Investigator and site staff without being on site?
- Required updates to study documentation
- Risks and Mitigations
- Application of lessons learned to future clinical trials
Interested in learning more about Beaufort can help your business? Email us at [email protected] or submit your request today.
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This webinar was recorded on November 3, 2020 in collaboration with Q1 Productions. Beaufort presenters were:
- Trish Landry, MBA, RAC, CCRP, Senior Vice President, Clinical Operations
- Leah Hollins, MPH, BA, Senior Clinical Project Manager