On 13 November 2020, the European Commission released MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR).
This elaborate guidance document addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII of the IVDR. Its primary purpose is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.As per article 47 of the IVDR devices shall be classified into classes A, B, C and D, considering the intended purpose of the devices as well as their inherent risks. The intended purpose, which is specified by the manufacturer in labelling, Instructions For Use (IFU), promotional/sales materials, statements and in the performance evaluation, thus determines a device’s regulatory life and must be clearly defined. Where there is a foreseeable risk that a device may be used for purposes which are covered by other classification rules and which would result in classification of a device into a higher class, a clear limitation of use should be included in the Instructions For Use (IFU) and the technical documentation of the device. For a device to be specifically intended for a purpose referenced in a particular classification rule, the manufacturer must clearly indicate that the device is intended for such a specific purpose in the information accompanying the device. Where several classification rules or sub-rules may apply, the intended purpose of the device and its claims, shall be sufficiently specified to enable a clear attribution of the class.
The majority of the guidance is dedicated to explaining the seven classification rules listed in Annex VIII of the IVDR. Furthermore, the document provides examples of diagnostic devices under each rule and includes an annex that gives examples of how IVDs used in combination should be classified.
What does this mean to you?
From this guidance it has once more been made very clear that the device’s intended purpose is crucial. You will have to carefully define the intended purpose of your devices and then determine the correct classification with the help of this useful guidance document. Keep in mind that the classification of a device impacts the conformity assessment route as well as many post-market requirements, it is thus of the utmost importance to establish clearly the purpose for which you will be placing your devices on the market and to build your documentation around this.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
