The Technical File is a dossier required for marketing a medical device in Europe (a.k.a. receiving the CE mark). For Class III devices, this is called Design Dossier and has a few additional requirements.
The Technical File is intended to show compliance with the applicable MDDs ( Medical Device Directives, the EU regulatory framework for Medical Devices).
It contains all the elements required to be able to produce the device (such as drawings, specifications, labels, etc.), relevant clinical data (e.g. clinical trials), the device risk management documents and specific MDD documents such as the Declaration of Conformity and the Essential Requirements checklist.
At a very high level, the required content is the following:
* General Information (on the sturcture and use of the Technical File),
* Device Classification per MDDs (Class I, IIa, IIb, III),
* Essential Requirements,
* Risk Analysis,
* Product Specifications,
* Design Control,
* Clinical Data,
* Test Reports (including lab tests, bench tests, biocompatibility, etc.),
* Packaging and Packaging Qualifications,
* Manufacturing specifications,
* Sterilization, including its validation ,
* Declaration of Conformity.
Unless you manufacture a non-sterile, non-measuring Class I device, a Technical File must be reviewed by a Notified Body.
Additional details can be found in the MDD, Annex II, par. 3. Part 4 is applicable only to Class III devices.
Europe’s new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) will change CE Marking and Technical File requirements for medical devices and IVDs. The MDR will come into effect in May 2020. With new requirements for clinical data and risk assessment, and an expanded product scope, technical files will need to be more detailed and robust to demonstrate compliance with the new regulation.
SoftComply can help you automate your medical device Risk Analysis and compliant Risk Reporting for your Technical File.