MDCG 2019-6 (Q&A on Requirements related to Notified Bodies) has been revised. Revision 5* is available: HERE

*There is a typo in the guidance document. The cover page correctly identifies the document as ‘Rev. 5’. However, the heading on each subsequent page incorrectly notes ‘Rev. 3’.

Overview of MDCG 2019-6 rev.5

MDCG 2019-6 is guidance on Notified Bodies (NBs), including how they should implement requirements related to their designation and operations.

This recent revision provides new and expanded definitions, such as consultancy vs regulatory guidance, personnel independence (e.g., the “cooling-off” period for NB personnel who previously worked for a manufacturer), and what is considered “leveraging evidence” to avoid duplication of work.

Further, one of the key changes is to add context on “structured dialogues”.

MDCG 2019-6 rev.5 and Structured Dialogues

Background on Structured Dialogues

Due to MDR/IVDR transition issues, MDCG 2022-11 (Notice to ensure timely compliance with the MDR/IVDR) and MDCG 2022-14 (Notified Body (NB) capacity/availability) “encouraged NBs to organise structured dialogue with manufacturers before and during conformity assessment”.

This was to facilitate a “smoother and faster process and to avoid incomplete applications, which have been identified as an important cause of the delays”. The structured dialogues were noted as especially important for small-to-medium sized manufacturers.

Team Notified Body (Team-NB) briefly addressed structured dialogues in its Code of Conduct (page 22). Further, some NBs have published information on their websites, such as TUV SUD here.

What exactly is a Structured Dialogue?

It is not quite similar to a US FDA Q-submission (pre-sub), which provides formal regulatory, scientific, and clinical feedback before submission. Instead, and as noted in MDCG 2019-6 rev.5, it is a discussion between a Notified Body and manufacturer that “should be focused on ‘what needs to be fulfilled’ rather than ‘how to fulfill’”. That said, it is a step toward providing manufacturers with more transparency during the CE Marking process.

What is the fee for Structured Dialogues?

Manufacturers should take advantage of this mechanism, considering that “costs related to structured dialogues should not entail extra fees but be integrated in fees related to pre-application and conformity assessment activities”. I.e., the Notified Body is expected to set its fees inclusive of structured dialogues. Therefore, manufacturers should capitalize on the option, as it is built into their fees whether they use it or not.

What can be discussed during a Structured Dialogue?

Structured dialogues are divided into two phases:

1. Pre-Application: Discussions may include device classification and identification of the MD/IVD codes, but do not allow feedback on assessing MDR/IVDR readiness or the acceptability of existing clinical data.
2. Post-Application: These dialogues permit more active discussions, such as evaluating the sufficiency of clinical data on which the clinical evaluation is based, and the appropriateness of the post-market clinical follow-up (PMCF) plan. The point is to provide clarity for the manufacturer; therefore, these dialogues may occur “in the early phase after submission” to “significantly increase the predictability of the conformity assessment process.”

NOTE: MedTech Europe, AESGP, MedTech & Pharma Platform, and COCIR published a joint position paper on MDCG 2019-6 rev. 5. It addresses the “ongoing absence of clinical strategy discussion in the pre-submission space“. And that, “as a consequence, the gap in clinical evidence expectations will persist – with serious consequences for our industry and for the continuity of devices“. The paper calls on the “European Commission and the EU Member States to address this situation as a matter of priority via the foreseen implementing act for the application of uniform rules for Notified Body requirements“.

MDCG 2019-6 rev.5 provides examples of topics in each phase:

Prior to the application (“pre- application”)	During the conformity assessment activities (“post-application”)11
Administrative questions   Timelines for conformity assessment until certification, including estimated timelines for possible special procedures, e.g. drug-device combinations, companion diagnostics or orphan devices Clarification on the data / documentation to be provided with the application If applicable, procedure related to the onboarding as a customer, including access to a possible portal, and relevant procedural guidance Options of conformity assessment procedures and – for legacy devices – timing for submission of individual technical documentation, i.e. discussion about the manufacturer’s “conformity assessment programme” Information on all necessary conformity assessment activities – e.g., initial audit, (annual) surveillance audits, technical documentation assessments, assessment of changes / change notifications – and any special (process) audits or additional (sub-) assessments / reports for TD assessment not explicitly mentioned in the Regulations; it should be specified if such activities are required or not and if they will be performed once or more often Pricing and fees Exchange of information about involved persons for different conformity assessment activities on both sites (notified body and manufacturer) including contact persons	Administrative questions   Clarification of missing data If test reports were initially not accepted, next steps regarding the submission of new test data Timelines for providing additional missing data Early information / discussion on a planned significant / substantial change of a product (design) and the consequences for the certification process
Regulatory guidance / requirements Applicable standards and guidance documents How to apply and reference standards or guidelines   Referring to the possibility of getting advice by EMA expert panels (Art. 106, Art. 61 (2) MDR, Art. 48 (6) IVDR)   Possibility of “modular approach” (e.g., review of specific parts of the technical documentation / clinical evaluation at different points in time, to allow (earlier) feedback on testing / evaluation strategies) General requirements regarding and acceptance of (third party) test reports / certificates Leveraging evidence from previous assessment (see Q&A IV.13)	Regulatory guidance / requirements Leveraging evidence from previous assessment (see Q&A IV.13) Appropriateness of equivalence claim (see Art. 61(4), second indent, MDR / Art. 48 (5) IVDR) Sufficiency of quality / quantity of clinical data Applicability of Article 61(10) MDR Appropriateness of PMCF plan
Technical information   Qualification and Classification of a product (Annex VII 4.2 (d) MDR/IVDR)   Requirements for sampling of devices for technical documentation assessments   Best practice guidance for technical documentation (TD), including preferred structure of TD	Technical information   Clarification of non-conformities raised