skip to Main Content
+44 (0) 1926 800 153 info@advenamedical.com

Medical Device Technical Document Compilation

(EU Technical Files)

The need for a detailed Technical File, i.e. the complete technical documentation needed to demonstrate that a particular Medical Device, or In-Vitro Diagnostic Medical Device, conforms to the regulations and is safe to place on the market, is essential for all devices, even those that are for low-risk.

The contents of such a Technical File will vary depending on the type and/or classification of the Medical Device, its intended use, whether it is sterile or not, and/or many other specific functions. However, for all Medical Devices the essential elements of technical documentation (Technical Files) are always going to be;

  • An assessment and rationale of the regulation to be used and then the classification chosen for the particular manufacturer’s intended use.
  • A description of the Medical Device and a statement of the manufacturer’s intended use.
  • A list of applicable European and/or International standards used in the design and manufacture.
  • A checklist against the essential requirements (General Safety and Performance Requirements GSPR under the new medical device regulation) of a particular regulation that you are claiming to conform to.
  • A risk management study to EN ISO 14971 that includes a review/summary of the residual risks after the manufacturer has taken all actions necessary to reduce risks.
  • Clinical evaluation report (EU Guidance MEDDEV 2.7.1 revision 4). This is an important document to demonstrate that the device is safe and efficient and state-of-the-art.
  • Bill of materials.
  • Information on external suppliers, materials and components used and approval rationale of suppliers and services. (And the supplier’s external quality certifications as applicable.) This includes packaging and sterilisation services.
  • Manufacturing process information and process validations as needed.
  • Biological / toxicological safety information
  • Copies of labels and instructions to be supplied with the device.
  • A Declaration of Conformity.

This is NOT a concise and final list, extra information may be and usually is applicable.

Back To Top