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 are directed to compile technical documentation with a comprehensive description of their device and that demonstrates its compliance with the European MDD.
Note: The European Medical Devices Directive (MDD) will be replaced by the Medical Device Regulation (MDR) on May 26, 2020.
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.
The European MDD makes no explicit reference to technical files, but instead refers to technical documentation. A technical file is essentially the European version of FDA’s 510(k) premarket submission. The purpose of a technical file is to demonstrate that your product conforms to the applicable and current medical device regulations.
Technical documentation must be produced and maintained for all medical devices sold in Europe. The format for technical files is known as Summary Technical Documentation (STED) and was explained in a GHTF document.
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 application should describe the design, manufacturing, and performance of the device and the documents needed to assess whether the product conforms to requirements. 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.
Manufacturers of Class IIa and IIb medical devices are not required to submit a design dossier for review 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.
This ultimately means that only Class III devices will require a design dossier to be submitted to a Notified Body. 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.
The European Commission is establishing new regulations for medical devices known as the European Medical Device Regulation (MDR). The MDR, which goes into effect on the 26th of May, 2020, will replace the currently applicable 93/42/EEC and 90/385/EEC Medical Device Directives (MDD). Medical device companies will still be required to maintain technical documentation respective to their products, and requirements for CE markings will remain roughly the same. One important change to note is the term "design dossier" will be replaced with "technical documentation."