Despite MDR coming into force in 2017 and fully enforceable on 26 May 2021, it is still unclear for medical device manufacturers how to submit at the first attempt a product Technical Documentation that is adequate to the requirements and potentially acceptable during the review by the Notified Body.
In order to facilitate the understanding of the structure and contents of the dossier, Team NB (European Association of Notified Bodies operating in the medical sector) published the guidance document Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745.
The aim of the guidance document is to illustrate the basic minimum requirements that must be included in the Technical Documentation when submitting it, thus establishing a standard level of expectations for Notified Bodies.
The guidance document first presents the most frequent causes of delays in the review of Technical Documentation, i.e. submission of incomplete documentation and inconsistency of the information submitted.
Secondly, based on experiences of failed or omitted reviews, the bodies provide some practical advice, including:
– Prior to submission, Manufacturers must clarify language requirements with their Notified Body in advance, as well as labelling requirements and documentation submission methods.
– It is necessary to:
- provide reports and data that are complete and as recent as possible,
- provide objective evidence of compliance with the applicable General Safety and Performance Requirements (GSPR),
- ensure the correctness and consistency of the information requested in all the different sections of the documentation also with respect to what is declared in the application form,
- justify any missing data
– Bodies may use evaluations carried out in the past under the directives to establish compliance with MDR requirements.
– The Manufacturer must continue to provide the complete Technical Documentation in line with MDR Annexes II and III.
Although each Notified Body has its own and peculiar guidelines that it is necessary to know and follow, in order to facilitate and speed up the reviewing process and thus achieve the certification objective, it is recommended that Manufacturers take into consideration the NB Team document, using it as a supplementary reference for their own internal dossier preparation procedure, already adapted to MDR Annexes I, II, III and IV.
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