MDCG 2020-16 Rev 2
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under IVDR.
This guidance plays a vital role for In-Vitro Diagnostics as it defines the classification categories. The primary purpose of this document is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market. Since the adaption of IVDR on 26th May 2022, it has become a known fact that In-Vitro Diagnostic Devices shall be classified into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks (Article 47). Robust risk-based classification rules are essential for the correct classification of devices according to Annex VIII as certain requirements set out by the IVDR are directly linked to device classification.
In Feb 2023, MDCG published second revised version where there were some
- Minor Revisions to certain examples
- Editorial Changes
- Revision to rule 3(f) [Companion Diagnostics]
- Addition of Annex 2
- Further revision to examples listed under Rule 5 (b) from the first revision [Instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures.]
Manufacturers and MDCG 2021 – 16 Rev 2
Here are some key points that medical device manufacturers should keep in mind from this guidance:
- IVDs are classified based on their intended purpose, with the highest risk devices being classified as Class D and the lowest risk devices being classified as Class A.
- IVDs that are intended to provide information about the predisposition to a disease or condition are considered to be the highest risk devices and are classified as Class D.
- IVDs that are intended for self-testing are generally classified as Class C or Class D, depending on the intended use and the risks associated with the device.
- The guidance provides specific rules for the classification of a number of different types of IVDs, including genetic testing devices, microbiology devices, and immunology devices.
- The guidance also provides detailed information on the criteria that should be used to determine the risk associated with a particular IVD, including the clinical significance of the information provided, the intended use of the device, and the complexity of the test methodology.
- Medical device manufacturers should carefully review the guidance to ensure that their IVDs are classified correctly under the EU regulations. This will help to ensure that the devices are subject to the appropriate level of regulatory oversight and that they are safe and effective for their intended use.
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