Description
Date of template: June 2025
What can you expect from this DoC template?
This DoC template is a document in open format ready to be filled in with the manufacturer’s details. It includes brief instructions, the declaration, and annex.
How can you know if this is applicable to your device?
This template is drafted for all medical devices under the Medical Devices Regulation 2017/745 (MDR), except for kits and custom made devices.
How do you buy this DoC template?
You can purchase our document directly on our website or with an invoice. Do you prefer paying with an invoice or have any questions on MDlaw, this product, or compliance in general? Contact us here or at mdlaw@obelis.net.
Disclaimer
This template is meant as a guidance only and the relevant regulations must always be followed.
For any questions on compliance of medical devices and IVDs, contact us here or at mdlaw@obelis.net.