Templates: Technical Documentation for Medical Device & CER

Hello. Thank you for your inquiry. Here are my answers:

1. Regarding the CER - no, we do not provide sample wording. However, each of our documents includes guidelines and additional explanations on how to complete the relevant sections.

2. The “Technical Documentation for Medical Device” template should be understood mainly as a technical documentation index / summary file rather than a complete MDR Annex II and Annex III template.

It provides a useful high-level structure for collecting and referencing key elements of the technical documentation, such as device identification, intended purpose, Declaration of Conformity, GSPR, applicable standards, design and manufacturing information, materials, risk management, biocompatibility, pre-clinical data, stability, sterilization, software, usability, labelling, IFU, clinical evaluation and post-market surveillance.

Should you wish to review the document in more detail, we can organize an online meeting and go through the template together. During the meeting, we can clarify which sections are already covered by the template, which supporting documents need to be prepared separately, and what additional content would be required to make the technical documentation fully aligned with MDR Annex II and Annex III.