The CE Technical file template has been developed following the requirements of the EU MDR 2017/745 Articles 10, Annex I, II, III and IX including all other necessary requirements. 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.
Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.
Our consultants are available, should you need further assistance in completing the documentation.