For each medical device, the manufacturer needs to prepare and keep up to date a technical documentation. The technical documentation under the MDR is comparable to a technical file or Design Dossier under the AMDD/MDD. However, under the MDR, we now have the advantage of Annex II and Annex III that outline in detail what needs to be part of the technical documentation. The requirement that the manufacturer needs to have a technical documentation comes out of Article 10. This initially states that the technical documentation needs to be available for each and every medical device.
The technical documentation needs to be prepared by the manufacturer and must be kept up to date. There is one new requirement in the MDR: the technical documentation must also be kept at the EU representative of a manufacturer that is not located in the EU.
When we start reading Annex II, we will find some very interesting words. The technical documentation needs to be clear, organized, unambiguous and readily searchable. These four terms are important for us as a reviewer or notified body, but also for you as a manufacturer, because you should keep those four principles in mind when combining all these documents into a technical documentation.
The main sections of the technical documentation – and also the main sections of Annex II – are the description of the device, the information supplied by the manufacturer, such as information in manuals or on labels, design and manufacturing information, general safety and performance requirements, which we know as Essential Requirements specified in the directives. Then we have risk and benefit elements that need to be in the technical documentation. And finally, the verification and validation of product and processes is also a very important part of the technical documentation.
