The article provides a general overview of the regulatory approach to be applied with respect to corrective actions.
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 various stakeholders, including conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs), on addressing non-compliances (NCs) identified during assessments under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
Introduction
This guidance complements MDCG 2022-13 and is intended to support stakeholders in creating, reviewing, and finalizing Corrective and Preventive Action (CAPA) plans for addressing NCs.
Key objectives include:
- Assisting NBs in developing CAPA plans based on NCs raised during joint assessments as per MDR and IVDR requirements.
- Providing DAs with guidance on reviewing and offering opinions on these CAPA plans.
- Supporting JATs in evaluating the CAPA plans and DA opinions during the assessment process.
To streamline this process, the necessary templates (Annex I: CAPA template, Annex II: JAT review template) are also provided for optional use, ensuring efficiency, consistency, and clarity.
In addition to the above, the MDCG emphasizes the importance of effective communication to maintain traceability and facilitate timely reviews by DAs and JATs.
Scope
The guidance focuses on using the provided templates during assessments and re-assessments of NBs under MDR and IVDR.
Applications include:
- Re-assessments of NBs.
- Designation assessments for CABs applying to become NBs.
- Scope extension reviews for NBs.
- Addressing challenges related to NB competence under MDR Article 47 and IVDR Article 43.
It is also important to mention that while comprehensive, certain elements (e.g., containment actions) may not apply to every assessment type. The CAPA template is primarily intended for NC documentation, but DAs may adapt it for their needs.
Timelines
According to the document, the key timelines are outlined in MDCG 2022-13, while stakeholders are advised to adhere to the specified schedules to ensure alignment with regulatory expectations.
Considerations for Notified Bodies (NBs)
The document further describes in detail the most important considerations for Notified Bodies.
For instance, NBs must transfer NCs from DA assessment reports into the CAPA template verbatim, including:
- Legal references.
- Classifications.
- Official translations, if applicable.
The CAPA template should be detailed and supported by relevant evidence (e.g., updated procedures) to facilitate DA and JAT reviews. Responsibilities for implementing CAPA actions should be assigned and documented, along with target completion dates.
Corrections
According to the document, corrections are immediate actions to address NCs. For critical risks, containment actions may be required without delay to mitigate potential harm.
Examples include:
- Restricting or suspending certificates.
- Addressing oversight in assessments (e.g., sterilization validation failures).
NBs must provide evidence of implemented corrections and consider their broader impact on:
- Quality management systems (QMS).
- Related procedures and documents.
- Other conformity assessment projects.
Additionally, NBs should proactively identify similar shortcomings elsewhere in the QMS to prevent recurrence.
Root Cause Analysis
According to the guidance, a thorough root cause analysis (RCA) is critical for understanding and addressing the underlying reasons for NCs.
Key steps include:
- Identifying the direct cause that resulted in the NC.
- Recognizing contributing causes that indirectly influenced the issue.
- Determining the root cause, which, once addressed, would prevent recurrence.
The RCA should encompass both the severity and extent of NCs. For systemic issues, implications for a broader range of potential NCs must be considered.
Conclusion
In summary, the key practices outlined in the document include:
- Clear Documentation: Maintain consistency in wording, legal references, and classifications while documenting NCs.
- Comprehensive CAPA Plans: Provide detailed corrections, preventive measures, and evidence to support actions taken.
- Timely Communication: Adhere to timelines and ensure effective dialogue among NBs, DAs, and JATs.
- Preventive Focus: Address observations and potential risks proactively to enhance overall compliance.
This structured approach ensures effective management of NCs, strengthening conformity assessment processes under MDR and IVDR.
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