European Commission’s Medical Devices Coordinating Group (MDCG) on 04-October-2021 issued guidance to support manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices.
The purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements.
According to MDR Article 51 devices are divided into the following classes I, IIa, IIb, and III, taking into account the intended purpose of the devices and their inherent risks. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest.
The guidance provides a high-level overview of the regulations and graphical summaries to explain medical device classifications, showing how the 22 rules in Chapter 3 of the MDR that govern categorization of medical devices intersect with the four risk classes of medical devices, and with each other.
Click on this LINK for a detailed explanation of the Guidance.