Factsheet for Class I Medical Devices ✔

The European Commission has released a handy factsheet for MDR Class I Medical Devices.  This is targeted at manufacturers of Class I devices, and covers devices already placed on the market under MDD, as well as new devices to be placed on the market for the first time according to MDR 2017/745

 Further information may be found in MDCG 2019-5.

 The factsheet covers:

-          Changes in Classification of Devices

-          New requirements for Manufacturers

-          Step-by-Step Approach for compliance

-          Frequently asked questions

🔗Original PDF: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_mdcg_2021_factsheet-cl1_en.pdf