This section explains in detail what structured dialogue between the applicant – generally the manufacturer, or its authorised representative acting within the scope of its mandate – and CMI, is, what it is based on and how it works. The Submission of an Enquiry, Application Submission and Issuance of a Certificate pages provide a brief summary of the structured dialogue options for the relevant stage of the process.
Structured dialogue is structured and documented communication between the manufacturer (or its authorised representative acting within the scope of its mandate) and the notified body. Its aim is to enhance the transparency, efficiency and predictability of the conformity assessment process through exchanges of technical information and regulatory guidance. In general, it focuses on what needs to be fulfilled and what the applicable procedure is, rather than on how the manufacturer should design a specific solution to achieve compliance. Responsibility for fulfilling the regulatory requirements remains with the manufacturer.
Structured dialogue is used both before an application for conformity assessment is lodged (pre-contractual / pre-application phase) and during conformity assessment after the application has been lodged (post-application phase). At CMI it may also be used in subsequent surveillance activities, when addressing changes and in connection with re-certification. The dialogue does not prejudge the outcome of the conformity assessment or the certification decision.
2.1 MDCG recommendations
The Medical Device Coordination Group (MDCG) recommended organising structured dialogues between manufacturers and notified bodies in point 15 of the position paper MDCG 2022-14 of August 2022. A detailed description of the permissible content and boundaries of structured dialogue is subsequently provided in particular by MDCG 2019-6 Rev.5, Questions I.6.1 to I.6.3. MDCG documents are not legally binding; however, under Section 1.6.2 of Annex VII to the MDR the notified body takes into consideration relevant guidance and best practice documents.
2.2 Relationship to the impartiality of the notified body
Under Section 1.2.3(d) of Annex VII to the MDR a notified body must not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment. At the same time, Section 1.2.9 of Annex VII to the MDR expressly permits exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying to it for conformity assessment. Structured dialogue uses precisely this scope: CMI may explain what the regulatory framework requires, what information is needed and how the assessment process works, but it must not propose specific solutions to the manufacturer on how to fulfil the requirements.
2.3 Distinction from scientific advice
Structured dialogue is not the same as „scientific advice“ under Article 61(2) of the MDR. A manufacturer of a class III device or a class IIb device referred to in Article 54(1)(b) of the MDR may, prior to its clinical evaluation and/or clinical investigation, consult an expert panel regarding the intended clinical development strategy and proposals for clinical investigations. Structured dialogue does not replace this scientific advice or the formal assessment of the clinical evaluation. However, it is not limited solely to administrative matters: after an application has been lodged, topics that may be discussed within it, within the limits of impartiality, include the sufficiency of clinical data, equivalence, the possible applicability of Article 61(10) of the MDR or the appropriateness of the post-market clinical follow-up plan (PMCF).
As a general rule, a structured dialogue may be requested by either the applicant or CMI. Its aim is to clarify procedures and regulatory requirements at an early stage and to limit unnecessary procedural delays. The dialogue can enhance the efficiency and predictability of the process, but does not in itself guarantee that the process will be shorter. No separate additional fee is charged for structured dialogue. Costs associated with the dialogue are included in the fees under the applicable price list. CMI nevertheless reserves the right not to provide a structured dialogue, particularly in the case of a repeated request or failure to cooperate in closing a previous dialogue.
The procedure and form of the request differ depending on the stage of the project:
- Before submitting an enquiry or application (pre-contractual phase): The applicant (whether an existing or new client) contacts the Order Administration Department (the relevant Order Administrator) by email.
- During conformity assessment or as part of surveillance activities: The applicant communicates directly with the assigned Project Leader through the electronic system MEDECA (by message) or by email.
3.1 General structured dialogue procedure
MDCG expects the main topics discussed as part of the structured dialogue to be documented. CMI uses an internally established procedure for this documentation, ensuring transparency and traceability:
- Initiation and preparation: The responsible person of one party contacts the other party with a request for a meeting. The two parties then clarify the list of items to be discussed, the date, the participants and designate the minute-taker.
- Conduct and record: The dialogue generally takes the form of a meeting. The outcome must always be a verifiable record – typically formal meeting minutes signed by both parties, or, exceptionally (for simpler procedural questions), email correspondence or communication through MEDECA, where both parties’ agreement on the subject discussed can be traced.
- Approval of outcomes: At the end of the meeting, the participants review the draft minutes. Within 3 working days of the meeting, the responsible persons of both parties give final approval to the minutes, which are then stored in MEDECA.
3.2 Relationship between structured dialogue and formal findings (non-conformities)
During conformity assessment, structured dialogue may be used to clarify missing data, the significance of identified deficiencies and non-conformities already raised. However, structured dialogue does not replace their formal recording, resolution and closure under the applicable conformity assessment procedure. CMI may explain what requirement or deficiency has been identified, what information is missing and what the next procedural step is; however, it must not propose a specific technical, clinical or documentation solution to the manufacturer for eliminating a non-conformity. The choice of correction and the submission of evidence of its implementation remain the manufacturer’s responsibility.
As part of a structured dialogue, CMI may discuss with the applicant in particular:
- before an application is lodged, preliminary verification of whether the product falls within the scope of the MDR, whether the proposed classification is correct and which MDR codes are relevant; for classification, see MDCG 2021-24 Rev.1; for codes, see MDCG 2019-14,
- whether CMI has the relevant type of device within its scope of designation and has available resources to assess it,
- the available conformity assessment procedures, their stages, the forms used, the documentation required and when it is to be submitted, any special procedures, acceptable languages, an indicative timetable and pricing conditions,
- applicable standards and guidance, general expectations regarding the organisation of technical documentation, technical documentation sampling and general requirements for the acceptability of third-party test reports or certificates,
- the possibility of a modular approach to assessment and of leveraging relevant evidence from previous assessments, where applicable to the case concerned,
- after an application has been lodged, missing data, the further process where a submitted test report is not accepted, time limits for supplementation, planned significant or substantial changes and their possible procedural consequences, as well as clarification of non-conformities already raised,
- after an application has been lodged, selected clinical evaluation matters, in particular the sufficiency of the quality and quantity of clinical data, equivalence, the possible applicability of Article 61(10) of the MDR and the appropriateness of the plan for PMCF,
- the scope and focus of surveillance activities, general rules for notification of changes, and the procedure and expectations associated with re-certification.
Structured dialogue does not replace formal conformity assessment and must not turn into a consultancy service. In particular:
- preliminary verification of the proposed classification before an application is lodged is possible, but CMI must not recommend changes to the design, intended purpose or other characteristics of the device with the aim of achieving the risk class sought by the manufacturer,
- before an application is lodged, structured dialogue may not include activities that already constitute conformity assessment, such as a review of clinical data, a partial assessment of the quality management system, a gap analysis / MDR readiness check or a „mock“ assessment of prepared technical documentation,
- CMI cannot provide a binding confirmation in advance of the outcome of a conformity assessment, surveillance activity, change assessment or re-certification, nor can it approve a specific solution proposed by the manufacturer in advance,
- the dialogue does not replace formal process steps (submission of an enquiry, application, change notification, submission of corrections, etc.), which must be carried out in the prescribed manner,
- the dialogue does not in itself suspend or alter agreed or procedural time limits unless expressly provided otherwise in the specific procedure.
| Process stage | What can be addressed in the dialogue | Example | Main limitation |
|---|---|---|---|
| 1. Submission of an enquiry (pre-contractual phase) | Preliminary verification of whether the product falls within the scope of the MDR, whether the proposed classification is correct and which MDR codes are relevant; scope of designation and available resources of CMI | Verification of whether new diagnostic software falls into class IIa or IIb under Rule 11 of the MDR | CMI may preliminarily verify the proposed classification, but does not propose changes to the device with the aim of achieving a lower or another class sought by the manufacturer; justification of the classification remains the manufacturer’s responsibility |
| 2. Application submission (conformity assessment) | Assessment timetable and scope; missing documentation; applicable standards and guidance; after the application has been lodged, also clarification of non-conformities and selected clinical matters (e.g. sufficiency of clinical data, equivalence, Article 61(10) of the MDR and the plan for PMCF) | Clarification of which parts of the technical documentation are to be submitted at the given stage and what the further process is if missing documentation is identified | CMI does not develop a specific solution on behalf of the manufacturer or approve a proposed correction in advance; a conclusion on conformity is reached only as part of the applicable assessment |
| 3. Issuance of a certificate and subsequent activities (surveillance) | Scope of surveillance activities; notification and assessment of changes; procedure and expectations for re-certification | Early discussion of a planned significant or substantial change and its possible procedural consequences for certification or surveillance | CMI may explain the procedural consequences, but does not approve the change in advance or guarantee the maintenance or extension of the certificate |