The Technical Documentation required by the current In Vitro Diagnostics Directive (IVDD) is largely left to the Manufacturer’s discretion. The contents are described, but to a limited degree, in a few bullet points in the IVDD’s Annex III (3). There is also mention of a “Design Dossier” in the IVDD’s Annex IV (4) in relation to the assessment of the design by Notified Body but it is not defined.
The above criticisms cannot be made of the new European Union In Vitro Diagnostics Regulation (EU IVDR) however. Annex II of the new EU MDR prescribes more than forty specific elements for the content of the (primary) “Technical Documentation”. Plus Annex III of the EU MDR requires more than fifteen additional elements in the “Technical Documentation on Post Market Surveillance”. The MDD’s “Design Dossier” has been dropped from the EU MDR.
Article 10 (4) of the EU IVDR makes the creation and maintenance of both parts of the Technical Documentation an obligation of all Manufacturers. The Technical Documentation is to be supplied to Competent Authorities when requested. A copy is also to be kept by Authorised Representatives (EU IVDR Article 11 (3)). It is also one of the items the “Person responsible for regulatory compliance” has to ensure is kept up to date (EU IVDR Article 15 (3)) and it is to be assessed by the Notified Body (EU IVDR Annex IX chapter II). In contrast to the IVDD, the new EU IVDR is consistent throughout on the subject of the Technical Documentation.
The (primary) Technical Documentation of Annex II of new EU IVDR is clearly based on the so called summary technical documentation or STED, developed by the former Global Harmonisation Task Force (GHTF). While not identical to the GHTF STED it is a remarkably close match; with just a few sections re-ordered or terminology adjusted to the European vocabulary. In contrast, the Technical Documentation on Post Market Surveillance described in Annex III of the new EU IVDR is less like a technical dossier, more like a collection of the procedures which make up the Manufacturer’s Post Market Surveillance system, together with the associated data and reports.
In the opinion of the author, the Technical Documentation is one topic which can and should be addressed by Manufacturers without delay. Regardless of when the first Notified Bodies will be designated, or when the UDI structure will be decided, or even when the EUDAMED database will be available. The Technical Documentation is going to be needed at some point for all devices. So Manufacturers are advised to immediately start mapping the Technical Documentation of the new EU MDR to their available documentation and to start work on filling any gaps.