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.
