A medical device or Invitro diagnostic device technical file is a comprehensive document that contains the information and data to demonstrate safety, efficiency, and performance. The core elements are design, technical specifications, components, materials, manufacturing processes, sterilization, packaging, labelling, instructions for use clinical evaluation and risk management. IVDR or MDR Technical File is an essential part of the device conformity assessment process by a Notified Body.
Contents of a Technical File
The elements that need to be in the technical file are the following.
· Name, UDI, patient population and their medical condition, principle of operation and rationale that the present product is a medical device.
· Classification and rule
· Description of accessories and, if applicable, system components, configuration/variations, constituent parts/components, raw materials, and elements with human body contact technical specifications
· Reference to previous and similar generations of the product.
· Information to be supplied by the manufacturer, device and packaging label and instructions for use.
· Design and manufacturing information on design and manufacture.
· General safety and performance requirements
· Benefit-risk analysis and risk management.
· Product verification and validation
· Preclinical and clinical data
· Information relevant for sterilisation, measuring function information.
· Description of combination/configuration with connected devices
· For implantable devices and class III devices report on safety and clinical performance
· Post-market surveillance plan, post-market surveillance report and periodic safety update report.
· Vigilance System
· Manufacturing Declarations
· Usability studies
· Shelf-life studies
· Performance Evaluation Report
Declaration of Conformity
The requirements for the Declaration of Conformity (DOC) are described in Article 19 and Annex IV of the Regulation (EU) 2017/745. The manufacturer has a written statement drawn to demonstrate the fulfilment of the EU requirements relating to the device for the CE marking. The DOC of the company fulfils the obligations imposed by Article 19 of Regulation (EU) 2017/745.
Information on the Label
The label should bear all the following particulars:
(a) Name or trade name of the device.
(b) Details strictly necessary for a user to identify the device, the contents of the packaging and where it is not obvious to the user, the intended purpose of the device.
(c) The name, registered trade name or registered trademark of the manufacturer and the address of its registered place of business
(d) Its registered place of business outside the Union if any, the name of the authorized representative and address of the registered place of business of the authorized representative.
(e) The lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate.
(f) The UDI carrier.
(g) An unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant.
Technical Consultants for Technical File
In brief, without consistent, standard-compliant, and well-written complete technical documentation files, medical device and invitro device manufacturers cannot prove that their products meet the GSPR. I3CGLOBAL stands ahead of others in EU MDR and IVDR technical documentation services for global manufacturers. Please do not hesitate to drop the I3CGLOBAL nearest location for more information.
