Guide to the MDR technical documentation

In a previous newsletter, we reported on the MDCG's position statement outlining the measures needed to accelerate the MDR/IVDR transition. This included a proposal that the MDCG and Notified Bodies provide additional guidance to help manufacturers prepare for the transition. In this line, TEAM NB (The European Association for Medical devices of Notified Bodies) has published a guidance document entitled "Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745".

The guide consists of a general part and detailed guidance on the content of the technical documentation. The document is 44 pages long, so we cannot go into details, but the general introductory part already contains useful information, which is briefly summarised below.

The guidance notes that the most common reasons for delays in review by Notified Bodies are:

• Incomplete submission - Information required for the conformity assessment activity is insufficient (incomplete) or missing.
• Lack of clear structure of technical documentation - Information is included in the technical documentation but is difficult to find.

TEAM NB suggests the following practical considerations to avoid delays:

• Communication with Notified Bodies before the application is submitted
  • It is necessary to clarify with the Notified Body the language requirements for the technical documentation referred to in the MDR in accordance with Article 52(12). So it is necessary to clarify in which languages our Notified Body will accept the technical documentation!
  • Clarification of the requirements for the labelling (marking) of the documentation and the means of submission to the Notified Body.
• Submission of technical documentation
  • Where applicable, the most recently updated comprehensive reports and data should be included. Abridged or partial test reports are not considered acceptable.
  • The test reports submitted should be complete, i.e. not only those reports that refer to subsequent modifications or revisions due to a change in the device.
  • The technical documentation should document how the manufacturer ensures compliance with all relevant GSPRs.
  • There are many parts of the technical documentation that require duplication of information in several documents, such as the device specification. Ensure that the information is correct in all areas where this information is repeated and consider the risk of potential errors/inconsistencies when updating (e.g. basic UDI-DI, UDI-DI, intended use, indications for use, contraindications, warnings, etc.).
  • Make sure that the information in the technical documentation is consistent with the information provided in the relevant conformity assessment application form.
  • In all cases, a valid justification must be provided or attached if there are (known) gaps in the information requested.
• Using evidence from directive (MDD, AIMDD) evaluations
  • In certain areas where the requirements have not changed significantly between the Directives and the MDR and the manufacturer's evidence of compliance with such requirements has not changed, notified bodies may use past NB assessments under the Directives to demonstrate compliance with the requirements of the MDR without having to reassess the evidence.
  • It is important to note that the manufacturer must still prepare the complete technical documentation in accordance with Annexes II and III of the MDR. However, the assessment process of the NB technical documentation would be facilitated if manufacturers clearly indicate whether or not the evidence/data submitted as part of the MDR application (or technical documentation) has changed from that previously reviewed/assessed by the notified body under the Directives. It will further expedite the process if the manufacturer refers to the reports issued by the NB in which it previously assessed the evidence under the Directive.

Download the TEAM NB documents here: https://www.team-nb.org/team-nb-documents/