The Technical Documentation required by the current Medical Device Directive (MDD) is largely left to the Manufacturer’s discretion. The contents are described, but rather vaguely, in a few bullet points in the MDD’s Annex VII. There is also mention of a “Design Dossier” in MDD Annex II but this is not further defined in the MDD.
The above criticisms cannot be made of the new European Union Medical Device Regulation (EU MDR) 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 of the EU MDR 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 MDR Article 11). It is also one of the items the “Person responsible for regulatory compliance” has to ensure is kept up to date (EU MDR Article 15) and it is to be assessed by the Notified Body (EU MDR Annex IX chapter II). In contrast to the MDD, the new EU MDR is consistent throughout on the subject of the Technical Documentation.
The (primary) Technical Documentation of Annex II of new EU MDR is clearly based on the so called summary technical documentation or STED, developed by the former Global Harmonisation Task Force (GHTF). However, it is not identical to the GHTF STED as there are a number of additional sections in the new EU MDR Annex II which reflect the specific focus of the European authorities on certain topics; information on medicinal substances, on tissues or cells of human or animal origin, on substances intended to be introduced into the human body. In contrast, the Technical Documentation on Post Market Surveillance described in Annex III of the new EU MDR 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.