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The European Union’s In Vitro Diagnostic Device Regulation (IVDR) came into effect on 26 May 2022.
The new European In Vitro Diagnostic Regulation (IVDR) will have several implications on clinical trials that use in vitro diagnostic devices (IVDs). Here are some examples:
Increased regulatory requirements: The new IVDR will impose stricter regulatory requirements for IVDs used in clinical trials, including the need for conformity assessments and the involvement of notified bodies. Sponsors will need to ensure that their IVDs are compliant with the new regulation, which may require additional testing and documentation.
Longer timelines: The increased regulatory requirements under the IVDR are likely to result in longer timelines for clinical trials that use IVDs. Sponsors will need to factor in the additional time required for regulatory compliance when planning their clinical trials.
Changes to clinical trial design: The new IVDR may require changes to the design of clinical trials that use IVDs, particularly with regard to the selection and use of IVDs. Sponsors may need to consider using alternative IVDs that are compliant with the new regulation or modifying their trial protocols to account for the increased regulatory requirements.
Impact on study endpoints: The use of IVDs in clinical trials can have a significant impact on study endpoints. The new IVDR may require sponsors to reassess their study endpoints and how they are measured to ensure that they are still valid and reliable in light of the increased regulatory requirements.
Data requirements: The new IVDR includes more stringent requirements for the collection and analysis of clinical data for IVDs. Sponsors will need to ensure that they collect the necessary data to meet the new requirements and that the data is analyzed and reported in compliance with the new regulation.
Overall, the new IVDR will have significant implications for clinical trials that use IVDs. Sponsors will need to carefully consider the new regulatory requirements when planning their trials and ensure that they are compliant with the new regulation throughout the trial process.
XPFORTE can offer a range of services to help sponsors navigate the EU IVDR while also considering the new EU CTR.
Regulatory strategy development: We can help sponsors develop a regulatory strategy that takes into account the requirements of both the new EU IVDR and EU CTR. This includes assessing the impact of both regulations on their clinical development programs, identifying potential challenges, and developing strategies to mitigate them.
Protocol development: We can assist sponsors in developing clinical trial protocols that are compliant with both the new EU IVDR and EU CTR. This includes ensuring that the protocols meet the new regulatory requirements, such as the new risk-based approach to monitoring under the CTR, and that they are aligned with the sponsor’s overall regulatory strategy.
Clinical trial applications: We can help sponsors prepare and submit clinical trial applications that meet the requirements of both the new EU IVDR and EU CTR. This includes preparing the necessary documentation, such as the Clinical Trial Application (CTA) and the IVD conformity assessment, Clinical Performance Study Protocols (CPSP) and ensuring that the applications are submitted on time and in compliance with all regulatory requirements.
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