The new article clarifies the aspects associated with the designation decision to be taken with respect to the applicant entity in the context of the CAB/NB designation process.
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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.
Final Review of the Implementation of the CAPA Plan
According to the guidance, before making a designation decision, the designating authority must verify the progress on the implementation of all Corrective and Preventive Actions (CAPAs) to address the non-compliances identified. The verification process includes determining whether non-compliances have been resolved or require further follow-up.
Verification outcomes include the following ones:
- Closed: The designating authority confirms that relevant CAPAs have been implemented effectively through documented evidence and/or on-site assessments.
- To be Followed-up: If actions are to be implemented according to a satisfactory schedule or have been implemented but still require verification of effectiveness, a follow-up date must be specified by the designating authority.
Considerations for CAPA Implementation
As further explained by the MDCG, when assessing the CAPA plan and conditions for designation, the designating authority must evaluate:
- Non-compliances to be addressed before designation: The proposed actions must be verified before issuing the final assessment report, while the effectiveness can be verified post-designation.
- Other non-compliances: Both the implementation and effectiveness of proposed actions can be verified post-designation.
Designating Authority’s Final Assessment Report
In accordance with the applicable regulations, there is no set deadline for the production of the final assessment report by the designating authority due to the variability in the number and nature of non-compliances identified. The CAB must implement CAPAs before the final report is produced. The final report should include the following elements:
Under the general rule, a report should contain:
- Assessment Results: A list of non-compliances and the assessment results.
- CAPA Verification: Confirmation that corrections and CAPAs have been appropriately implemented and verified.
- For each non-compliance, the designating authority’s assessment of the CAB’s proposed CAPAs.
- Verification of the implementation of corrections and CAPAs.
- Assessment of the effectiveness of the implemented CAPAs, where required.
- Diverging Opinions: Any remaining diverging opinions with the JAT.
- Scope Recommendation: Recommendations on the CAB’s proposed scope of designation, including detailed information if the recommended scope differs from the applied-for scope.
Language Requirements
While the final assessment report is typically in the language of the Member State, the Key information document (reference MDCG 2019-12) must be completed in English to facilitate understanding by the JAT and the MDCG. If the recommended scope of designation differs from the applied-for scope, this should be explained in the Key information document.
Submission of the Final Assessment Report to the Commission
The designating authority must submit its final assessment report, the Key information document, and, if applicable, the CAB’s draft designation to DG SANTE, which will then transmit these to the MDCG and the JAT. DG SANTE will acknowledge receipt via email to the designating authority.
For reports and draft designations not in English, DG SANTE will arrange for machine translation, which will be shared with the MDCG. The designating authority may inform the CAB of the submission to DG SANTE according to its own procedures.
JAT Final Opinion
SANTE will submit the JAT final opinion to the MDCG and the designating authority. The JAT final opinion will include:
- JAT Assessment Summary: A summary of the off-site and on-site assessments.
- CAPA Plan Assessment: A summary of the JAT’s assessment of the CAPA plan and the designating authority’s opinion, including progress in implementation and verification.
- Diverging Opinions: Updated diverging opinions and their potential impact on the MDCG’s recommendation.
- Scope Opinion: The JAT’s opinion on the designating authority’s recommended scope of designation and, if applicable, the CAB’s draft designation.
The JAT coordinator will facilitate agreement on the JAT final opinion among all JAT members via teleconference or alternative arrangements such as email exchanges. Any lack of consensus will be recorded.
MDCG’s Recommendation on the Draft Designation
Within 42 days of receiving the JAT final opinion, the MDCG will issue a recommendation on the CAB’s draft designation proposed by the designating authority. According to the guidance, the recommendation process should include:
- Proposal Preparation: The MDCG chair will coordinate the preparation of a recommendation proposal, which will be shared with MDCG members for comments.
- Consultation: The MDCG will be consulted on the proposed recommendation either during a meeting or through a written procedure. A dedicated meeting may be arranged if necessary.
The final MDCG recommendation, endorsed by the MDCG, will be uploaded to the CIRCABC Workspace and forwarded to the designating authority and all MDCG members.
The designating authority will make its final decision on designation according to its own procedures, taking into account the MDCG’s recommendation.
Conclusion
In summary, the present guidance describes in detail the processes and procedures pertaining to the final destination decision to be taken, allowing an interested party to commence its activity as a conformity assessment / notified body.
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