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This is a general template for all classifications which can be adopted to suit your needs. The CE tech file template also includes the General Safety and Performance Requirements Annex I in a tabulated format.
A preview of the CE Technical File is available here:
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All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.
This document was designed to provide guidance to manufacturers of medical devices to help them understand the requirements for clinical evaluation and investigation of their product(s) under the new EU Medical Device Regulation 2017/745.
A preview of the Clinical Evaluation Guidance Document is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
All medical devices require a clinical evaluation and a clinical investigation in order to prove that the product is safe to be used by the intended users and that it achieves what the manufacturer claims the device was designed for, i.e. the device’s intended use.
A preview of the Clinical Evaluation Template is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The design and development plan simplify the intended project, as It identifies the aim of the project and its uses, states the strategy required for regulating the project and critical risks associated, breaks down the project’s associated work and defines the project phases from concept to handling in addition to the needed supplies and the project milestones.
A preview of the Design & Development Plan is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The design inputs are used in the design planning and realising phase, and prior to the design validation and verification phase.
A preview of the Design Inputs is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The design traceability matrix is intended to obtain information and requirements associated with the project.
The design transfer plan documents the process and the activities which are needed to transfer the device/part from the design phase into the manufacturing/production phase.
The design transfer report documents the activities and the processes that has been used in the plan, to report any failures and to state whether the acceptance criteria have been met.
The design validation protocol is used to highlight and identify the process needed to validate the customer requirements of the product by testing samples and making records of the results.