The new article describes the activities taking place during the on-site assessment.
Table of content
The Medical Device Coordination Group (MDCG), the European agency focused on further improvement of the medical device regulatory framework, has published a guidance document dedicated to the designation, re-assessment, and notification of conformity assessment bodies and notified bodies. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Furthermore, they could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
JAT Summary Assessment Report
The scope of the guidance covers the aspects related to the assessment report. In particular, it is explained that after the on-site assessment, the Joint Assessment Team (JAT) coordinator, in coordination with the JAT team, prepares a draft summary assessment report.
This report, which includes any remaining diverging opinions, is submitted to the designating authority within 30 days of the on-site assessment’s completion. The report details the scope assessed and serves as the basis for the designating authority’s designation decision to be taken.
The draft report covers the assessment by the JAT and the list of non-compliances provided by the designating authority at the closing meeting. It also documents any disagreements regarding the presentation of non-compliances or the JAT’s assessment summary.
Under the general rule, the designating authority has 25 working days to review the draft, provide comments, and confirm or clarify its views. Any errors in the applied-for scope should be highlighted during this period.
Taking into account the designating authority’s feedback, the JAT coordinator finalizes the summary assessment report within 15 working days. The final report, which includes any unresolved diverging opinions, is then submitted to the designating authority.
Assessment of the CAPA Plan by the Designating Authority
The document also outlines the approach to be followed by the parties involved with respect to specific corrective and preventive actions. As explained by the MDCG, upon receiving the Corrective and Preventive Action (CAPA) plan from the CAB, the designating authority assesses it to ensure all non-compliances and diverging opinions identified during the assessment are addressed.
The authority verifies that:
- All non-compliances are included in the CAPA plan.
- Root causes are appropriately identified and assessed.
- Corrections are identified and implemented where appropriate.
- CAPAs and their implementation deadlines are defined.
- Effectiveness verification actions and timeframes are specified.
The document also outlines the applicable classification rules, prescribing that each action proposed in the CAPA plan is classified as:
- Satisfactory: Proper root cause analysis, adequate corrections, CAPAs, implementation deadlines, and defined processes for verifying effectiveness.
- Unsatisfactory: Insufficient or unclear information, inadequate to address non-compliances or prevent recurrence. The designating authority provides a rationale and specifies what additional information is required.
If any CAPAs are unsatisfactory, the designating authority requests a revised CAPA plan within a specified deadline. This process may involve several rounds of assessment for clarification and verification.
If the CAB fails to provide satisfactory clarifications or modifications, the designating authority may stop the assessment process and inform DG SANTE. Within 20 working days of receiving and assessing the CAPA plan, the designating authority confirms the plan and drafts an opinion on its adequacy.
This opinion, along with the confirmed CAPA plan, is forwarded to DG SANTE. The CAPA plan should be provided in both PDF and DOCX formats, ideally in English or with an acceptable English translation.
JAT Review of the CAPA Plan
In accordance with the relevant procedure, DG SANTE acknowledges receipt of the CAPA plan and the designating authority’s opinion via email. If needed, the documents are machine-translated to expedite the JAT’s appraisal.
The JAT coordinator forwards the translated CAPA plan to national experts for comments. Within 40 working days, the JAT provides its CAPA review to the designating authority.
This review includes:
- Acceptance of the CAPA plan and root cause analyses.
- Requests for clarifications or additional information.
- Identification of any unacceptable actions.
Feedback to the CAB
During the next step, the designating authority finalizes its assessment of the CAPA plan based on the JAT’s review and provides feedback to the CAB. If amendments are needed, a deadline is established for these changes.
The designating authority updates its assessment until the CAPA plan content is satisfactory, keeping DG SANTE informed of progress. The MDCG additionally emphasizes the importance of constant communication between the designating authority and the JAT throughout this iterative process to ensure all issues are addressed.
The designating authority informs the JAT coordinator about the expected timing of the CAPA plan’s submission and keeps all parties updated on subsequent developments.
Conclusion
In summary, the document describes in detail specific post-on-site assessment activities intended to ensure conformity assessment bodies meet all regulatory requirements, maintaining high standards for the designation and re-assessment as set forth under the applicable legislation.
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