At the beginning of October 2021, Medical Device Coordination Group (MDCG) published the fundamental guideline MDCG 2021-24 “Guidance on classification of Medical Devices” on Medical Devices classification.
Medical Devices classification
The Medical Devices classification is a system based on risk considering the vulnerability of the human body and the potential danger associated to devices.
This approach uses a certain number of criteria that can be combined in different ways in order to establish Medical Devices classification, such as: contact time with the human body, invasiveness, potential toxicity, the body part involved in the use of the Medical Device, and if the device is connected to some kind of power source.
These criteria can be applied to a large variety of devices and technologies and they constitute the “classification rules” established in the Annex VIII of the Medical Devices Regulation MDR (EU) 2017/745. Most of them correspond to the classification rules laid down by the International Medical Device Regulators Forum (IMDRF) GHTF/SG1/N77:2012.
According to the MDR Article 51, Medical Devices are divided into the following four risk class: I, IIa, IIb, and III.
MDCG 2021-24 guideline’s aim
The MDCG 2021-24 guideline’s aim is to provide a general overview on Medical Devices classification impact on several aspects concerning device compliance with regulatory requirements.
In particular, MDCG guide presents a series of chapters providing information about:
- Terms and definitions.
- How to conduct the classification.
- Classification rules application.
In addition, you can find flow charts and specific examples explaining every rule of Medical Device classification.
Which and how many classification rules are there?
The classification rules available in the Annex VII MDR and explained in the MDCG 2021-24 guideline are 22 and they are divided according to the types of Medical Devices:
- Non-invasive, rules from 1 to 4.
- Invasive, rules from 5 to 8.
- Active, rules from 9 to 13.
Moreover, there is a series of special rules (14 to 22) addressed for example to birth control devices or devices containing/ made with nanomaterials.
Do you need further information on Medical Devices classification?
MDCG 2021-24 guideline, along with MDR (EU) 2017/745 Regulation, provides useful information on Medical Devices classification.
If you are seeking support on devices classification, please contact us at sales@thema-med.com.
Source:
MDCG 2021-24 “Guidance on classification of Medical Devices”, MDCG, Ottobre 2021
