Class I Medical Devices: Achieve MDR compliance in 9 steps -- MEDICA - World Forum for Medicine

25.08.2022

Obelis SA OBELIS GROUP

Class I Medical Devices: Achieve MDR compliance in 9 steps

Classifying a medical device under Regulation 2017/745 (MDR) means considering its intended purpose and inherent risks. Like under the old Directive, Class I devices present a low risk to patients and end users. However, the new Regulation has introduced more rules, leading to some devices being upgraded to Class IIa, IIb, or even III.

To help Class I manufacturers comply with the new regulation by May 26, the European Commission (2021) has released a useful factsheet. The document shows the necessary steps for compliance in a more immediate and user-friendly way, by summarising the MDCG guidance on the same topic (MDCG 2019-15 rev. 1, 2020).

What are the nine steps towards MDR compliance?

Exhibitor Data Sheet