Tag: MDR requirements

Product compliance

2021-04-13

What is Risk Management, and How to Create a Risk Management Plan?

Learn what a medical device risk management plan is and how to create one.

CE marking

2021-03-02

Medical Device Technical File for MDR Compliance

This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.

CE marking

2021-02-16

10 Medical Device Symbols You Must Know About

MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.

CE marking

2021-02-11

EU MDR Labelling Requirements for Medical Devices

This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.