The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
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.
The scope of the guidance covers, inter alia, on-site assessment activities to be conducted in order to evaluate compliance with the relevant regulatory requirements.
Scope and Organisation of the On-Site Assessment
According to the document, the on-site assessment process is integral to the evaluation of conformity assessment bodies (CABs) seeking designation as notified bodies (NBs) under the MDR or IVDR. The relevant section of the document outlines the scope and organization of these assessments, detailing the roles of the designating authority team and the joint assessment team (JAT).
The designating authority team leads the on-site assessment with active participation from the JAT. The assessment covers all designation requirements outlined in Annex VII of the MDR and IVDR, alongside other relevant regulations.
It is also important to mention that while certificates issued under Articles 16 MDR/IVDR and 17 MDR are excluded from joint assessments, the designating authority may independently evaluate these activities. The assessment should follow a pre-defined plan, and efforts should be made to maintain the planned schedule. Evening coordination meetings are recommended to reduce time spent on-site.
Opening Meeting
Before the opening meeting, the designating authority team and JAT hold a coordination session to clarify outstanding issues, define roles, and organize practicalities. This pre-meeting ensures the smooth conduct of the on-site assessment.
The designating authority team leads the opening meeting, covering:
- The legal basis for the assessment
- Confirmation of the applied-for scope
- Introduction of team members
- Description of the designation process
- Explanation of the assessment plan
- Confidentiality rules
The CAB then presents its organization and introduces its personnel. The JAT may provide additional clarifications during this session.
Conduct of the On-Site Joint Assessment
The designating authority team and JAT split into sub-teams to cover four main areas: organizational and general requirements, quality management system requirements, resource requirements, and process requirements. Sub-teams are formed based on expertise, with some focusing on personnel files and others on the main assessment areas.
Interpreters support each team as necessary. As explicitly stated by the MDCG, constant communication between the designating authority and JAT is essential. Regular coordination meetings are held to discuss findings. The designating authority may also debrief the CAB daily.
The MDCG further acknowledges that different interpretations of legal requirements may arise. Such issues are discussed in private coordination meetings between the designating authority and JAT to reach a consensus. Diverging opinions should be duly documented if consensus is not achieved.
List of Non-Compliances
Under the general rule, any and all non-compliances identified during the assessment are recorded against specific legal requirements. These are classified as major or minor, indicating whether corrective actions must be verified before or after designation.
Observations, where no legal requirement is breached, are also noted. The JAT coordinator collates non-compliances daily, sharing them with the designating authority for discussion.
A final list of non-compliances is agreed upon before the closing meeting, with any unresolved diverging opinions documented in the summary assessment report.
Closing Meeting
The designating authority leads the closing meeting, presenting:
- Re-confirmation of the applied-for scope.
- List of non-compliances.
- Remaining diverging opinions.
- Description of the post-assessment designation process.
- Requirement for a corrective and preventive action (CAPA) plan.
- Confidentiality rules.
The JAT coordinator summarizes the JAT’s assessment, highlighting any diverging opinions.
Post-Meeting Documentation
Under the general rule, changes to the non-compliances list after the closing meeting should be communicated in writing within five working days. The final version should be uploaded to the CIRCABC dedicated workspace.
The CAB must submit a CAPA plan within a specific deadline, considering the complexity of identified non-compliances. Ideally, this plan is submitted within three months of the on-site assessment.
The CAPA plan should include:
- The root causes of non-compliances
- Corrections and CAPAs with specified implementation deadlines
- Actions to verify CAPA effectiveness, including review timeframes
Problems in Completing the On-Site Assessment
The document also highlights certain potential problems that could arise in the course of or in connection with the on-site assessment and outlines the suggested approach to be followed. For instance, it is stated that in exceptional cases, if the assessment cannot cover all designation criteria, options for extending the assessment are considered.
This may involve scheduling additional on-site assessments at a later date. If the designating authority believes the assessment is complete but the JAT disagrees, this disagreement is documented in the JAT summary assessment report.
Conclusion
In summary, the present guidance describes the comprehensive procedures and protocols to be followed during the on-site assessment of CABs, ensuring thorough evaluation and consistent application of regulatory standards.
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