To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practice guidance documents that each Team NB notified body member had submitted. They then prepared this best practice guidance document.
The requirements of Annexes II and III of the Medical Devices Regulation [MDR] (EU) 2017/745 are linked with this technical documentation submission advice.
Information that is needed for the conformity assessment activities is not given in adequate amounts or is missing entirely.
The typical roadblocks for notified bodies’ evaluation of technical documentation are:
- Information that is needed for the conformity assessment activities is not given in adequate amounts or is missing entirely.
- Although difficult to find, the information is supplied in the Technical Documentation.
Please take into account the following useful information to prevent delays and enhance your submission:
- According to Article 52 of the MDR, manufacturers should get in touch with their notified body to get clarification on the linguistic requirements for submitting technical documentation to that specific notified body (12).
- Manufacturers should also get in touch with their notified body to find out more about the specifications for documentation labeling and submission procedures.
- The most recent thorough reports and statistics should be presented, where applicable. Test reports that are shortened or just partially completed are not accepted.
- The verification reports offered should be comprehensive; that is, they shouldn’t have been amended or revised when the device changed.
- The technical documentation must explain how the producer guarantees adherence to each GSPR that is relevant.
- Duplicating information for many publications is necessary in many technical documentation fields, such as device descriptions.
- Please check that the information is accurate in all places where it appears twice and take into account the possibility of inconsistencies when updating.
- Make sure the information given in the corresponding application forms and the technical documentation is accurate and consistent.
- Where there are gaps in the requested data, valid justifications should always be offered or included.
Manufacturers are required by the EU MDR to submit an initial application to notified authorities for certification under MDR for certain categories of medical devices (NBs).
Before certification can be awarded, NBs are needed to carry out the necessary conformity assessment procedures, which typically involve a combination of quality management system audits and technical documentation assessments to confirm compliance with the MDR 2017/745 standards. NBs may be able to use prior NB assessments conducted under the Directives to establish compliance with the MDR requirements without having to reevaluate the evidence in some cases where the requirements have not changed significantly between the Directives and the MDR and the manufacturer’s evidence to meet such requirements has not changed. Such a strategy could promote to a quicker transition of medical devices from the Directives to the MDR by reducing duplication and the length of the NB MDR conformity assessment processes.
It’s vital to remember that the producer must keep delivering thorough technical documentation in accordance with the MDR’s Annex II and Annex III. However, it would help the NB technical documentation assessment process if manufacturers made it clear whether or not the evidence they submitted as part of an MDR application (or technical documentation) has changed; the extent of changes in comparison to what might have previously been examined by their notified body under the Directives (this may be provided separately or included in the GSPR checklist); and references to NB reports where such evidence was previously mentioned.
