Many manufacturers may very well already be feeling the benefits of the new EU IVD Regulation 2017/746. Approved on April 5th of this year, and in force as of May 26th, the new regulation did much to tackle previous issues felt by manufacturers and distributors alike struggling to introduce their IVD devices to the European Market on account of homogeneity in the scope of device classification.
Under the new regulation (IVDR 2017/746) the entire classification system has been updated. In place of the old system is now a risk-assessment based model involving a new set of classifications (introducing classes A – D). The system has been said to have been based on Global Harmonization Task Force (GHTF) requirements, not dissimilar to the current Health Canada and TGA classification rules.
There are a number of major changes being introduced in IVDR 2017/476 that should be noted across the board. Firstly, while under the previous directive Notified Bodies were only required for a few high-risk IVDs listed in Annex VII, the new system dictates that the conformity assessment process for CE marking for a vast majority of the newly classified devices will necessitate the involvement of a Notified Body – as opposed to the previous method of self-declaration. This will be especially relevant for previously self-declared devices moving to Classes C and D which will now require a large amount of additional documentation, as well as evidence of safety and performance.
Along with this, IVDR 2017/746 prohibits the grandfathering of CE Marking under the Medical Device Directive. As of May 26th 2017, all products (regardless of previous status) will need to be CE marked afresh. Accessories, independent software, and IVDs for near-patient testing will be classified in their own right. Software which drives a device or influences its use, calibrates, or controls with assigned values will be assigned the same classification as the associated device. It’s important to note that where more than one rule applies to a produce, the highest classification will be used.
The classes introduced under IVDR 2017/746 are as follows:
- Class A: Devices with low risk to public health. E.g. specimen receptacles, products for general lab use, accessories with no critical characteristics, culture media, instruments intended for IVD procedures, etc.
- Class B: Devices with moderate to low risk. E.g. clinical chemistry tests, some self-assessment IVDs.
Note: Class B is the default classification when no other ruling applies
- Class C: Devices with moderate risk to public health. E.g. compatibility tests for transfusion, transplantation, cell administration (excluding high-risk blood grouping), tests for infectious disease / STI agents / cancer biomarkers / companion diagnostics / genetic testing / TORCH screening / congenital disorders / monitoring high risk medicines / substances.
- Class D: Devices with high risk to public and personal health. E.g. devices for screening for transmissible agents and high-risk blood grouping for transfusion, transplantation, cell administration; life-threatening transmissible agents; screening where there is a possible high risk of propagation, and detection of infectious load where monitoring determines patient management.
To get a more detailed account of how the new IVD regulation may affect your IVD devices, to learn about CE marking or the EU compliance process, or to simply lodge an enquiry with Obelis’ team of EU regulatory experts, contact us today!