The new article pays special attention to the role of the key parties involved.
Table of content
The Medical Device Coordination Group (MDCG) has published a guidance document dedicated to corrective and prevention action (CAPA) plan assessment, addressed to conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams. The document describes in detail the relevant regulatory requirements based on the existing legal framework and also provides additional clarifications and recommendations to be taken into consideration by all the parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. In particular, the document provides detailed guidance for Designating Authorities (DAs) and Joint Assessment Teams (JATs) on their roles in assessing Corrective and Preventive Action (CAPA) plans to address non-conformities (NCs) under the MDR and IVDR regulations.
Considerations for the Designating Authority (DA)
The DA plays a crucial role in evaluating the CAPA plan developed by the notified body (NB).
The DA’s responsibilities include:
- Completing the assessment section of the CAPA template in sufficient detail to ensure clarity for the JAT, reducing the need for additional clarifications.
- Following the process outlined in MDCG 2022-13 for assessing CAPA plans.
- Clearly communicating expectations to the NB, especially for findings classified as observations, and guiding them on how to address these observations effectively.
Collaboration with the JAT
Once the CAPA plan is confirmed:
- The DA forwards the CAPA plan along with its assessment to the JAT.
- Upon receiving the JAT’s feedback, the DA carefully reviews the input, finalizes its overall assessment, and provides the NB with feedback and follow-up steps.
- If the JAT requests further modifications, the DA may ask the NB to revise the CAPA plan and subsequently update its own assessment.
This iterative process continues until the DA and JAT reach agreement on the CAPA plan. The aim is to resolve NCs early in the process, although further iterations may be needed during the implementation phase.
Verifying Implementation
For actions requiring implementation before the DA’s final report, the DA must:
- Document the verification process in the CAPA template, including:
- Evidence reviewed.
- Conclusions reached.
- Confirm successful implementation of the NB’s actions and provide detailed documentation or descriptions for the JAT during the CAPA assessment phase to prevent negative outcomes.
If providing documentation is impractical, the DA should include a thorough description of its assessment in the CAPA template. This ensures the JAT has enough information to concur with the DA’s conclusion, particularly regarding major NCs being resolved.
Considerations for the Joint Assessment Team (JAT)
The JAT reviews each CAPA plan update provided by the DA to ensure that:
- The plan is aligned with regulatory requirements.
- The DA’s assessment of the CAPA plan is clear and comprehensive.
The JAT completes its review using the JAT review template, documenting:
- Acceptance of the CAPA plan, including corrections, root causes, and corrective actions, if they meet regulatory requirements and align with the DA’s assessment.
- Requests for further clarifications, such as when specific details about planned changes in a procedure are missing.
- Requests for modifications if corrections, root causes, or actions are deemed unacceptable, insufficient, or inadequate. The JAT provides detailed reasoning for such requests in the review template.
As further explained by the MDCG, the JAT focuses solely on:
- CAPA plans addressing NCs that breach legal requirements.
- Assessing the DA’s opinion on these CAPA plans.
At the same time, it is important to mention that the JAT does not review:
- NB actions related to observations, as these do not constitute breaches of legal requirements.
- DA opinions on observations, as they fall outside the scope of legal compliance issues.
Conclusion
In summary, the key practices for DAs and JATs include:
- Clarity and Detail: Both the DA and JAT should ensure their assessments and feedback are clear, detailed, and well-documented to avoid repeated clarifications.
- Collaboration: An iterative process involving the DA, JAT, and NB ensures all NCs are thoroughly addressed and resolved efficiently.
- Proactive Verification: DAs should document evidence and assessments during the CAPA implementation phase to facilitate the JAT’s review and reduce the likelihood of disagreement.
- Efficient Resolution: Both parties should aim to reach an agreement on the CAPA plan early in the process, ensuring the timely and satisfactory resolution of NCs.
In such a way, DAs and JATs can effectively manage their responsibilities in the CAPA process, ensuring compliance with MDR and IVDR regulations.
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