The design dossier should include the technical documentation, along with a declaration of conformity and a description of the design, manufacturing, and performance of the device. This ultimately means that only Class III devices will require a design dossier to be submitted to a Notified Body. Additionally, the European MDD allows manufacturers of Class I medical devices to carry out their own conformity assessment activities because of the low-risk classification associated with the product. Manufacturers of Class IIa and IIb medical devices are not required to submit a design dossier for review to a Notified Body. Difference between a technical file and design dossier All contents of the technical file should be included in the design dossier, as the purpose of the technical file is to demonstrate conformity with the applicable directives or regulations. The application should describe the design, manufacturing, and performance of the device and the documents needed to assess whether the product conforms to requirements. Under section 4 of Annex II of the European MDD, medical device manufacturers entering the European marketplace must have their design dossier examined by a Notified Body. The format for technical files is known as Summary Technical Documentation (STED) and was explained in a GHTF document. Technical documentation must be produced and maintained for all medical devices sold in Europe. The purpose of a technical file is to demonstrate that your product conforms to the applicable and current medical device regulations. A technical file is essentially the European version of FDA’s 510(k) premarket submission. The European MDD makes no explicit reference to technical files, but instead refers to technical documentation. While the requirement for medical device companies to produce and compile technical documentation is made explicitly clear in the directive, the distinction between a design dossier and technical file has been the cause of significant confusion for quality and regulatory professionals who must adhere to it.įREE DOWNLOAD: Click here to download a helpful checklist for structuring your technical documentation.

Note: The European Medical Devices Directive (MDD) will be replaced by the Medical Device Regulation (MDR) on May 26, 2020. Medical device companies are directed to compile technical documentation with a comprehensive description of their device and that demonstrates its compliance with the European MDD. Medical device companies who wish to sell their devices in the European market must obtain a CE marking by following the procedure for EC Declaration of Conformity outlined in Annex II of the European Medical Devices Directive (MDD).

Medical device companies selling into the European marketplace must understand how the Competent Authorities distinguish between a Technical File vs Design Dossier

Ce technical file sample