Technical Documentation format under the MDR and IVDR

The requirements under the Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive (93/42/EEC, MDD and 98/79/EC, IVDD) for the set-up of technical files were very general in nature.

The Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation (2017/745, MDR and 2017/746, IVDR) are much more specific in this regard. Annexes II and III of the Regulations give an overview of the required contents and may also be used as a top-level structure of the technical documentation. Alternative formats, e.g. STED may be used, but the suggested contents must be included.

Please be aware that reviewers are obliged to not accept technical files that do not fulfill the requirements mentioned above.

Furthermore, both Regulations say that the technical file “shall be presented in a clear, organised, readily searchable and unambiguous manner” (MDR and IVDR, annex II).

Should you have any questions, please don’t hesitate to get in touch with our team.

Sources: MDR, IVDR

For further in depth information on changes accompanying the new regulations, we warmly recommend following articles and pages

Technical Documentation Requirements under the MDR – a Case Study
Supportive Information Section MDR/IVDR
Major Aspects of the MDR
Major Aspects of the IVDR