…for many manufacturers of products for general laboratory use like pipettes, centrifuges, thermocyclers or glass microscope slides.
Some manufacturers are in the mistaken belief, that their device is regulated by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Other manufacturers would simply like to market their device as an IVD for marketing purposes. In both cases they declare their “general laboratory use” device as an IVD, try to create the Technical Documentation, sign the Declaration of Conformity and affix the CE mark. However, many of them overlook the fact that their device does not fall under the scope of the IVDR at all. In doing so they encounter numerous problems during the conformity assessment, especially when drawing up the performance evaluation.
These manufacturers classify the device as Class A by referring to IVDR classification rule 5a and b, reading only the first part: “The following devices are classified as class A: a) products for general laboratory use, … b) Instruments (…)“. But they overlook the second part of those rules: “… a) intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination. b) intended by the manufacturer specifically to be used for in vitro diagnostic procedures”. However, this second part is absolutely essential: It determines if your device falls definitively under the scope of the IVDR or not.
Here is an example: If your device is an ELISA analyzer but it is not specifically intended to be used for in vitro diagnostic procedures and could for example be used by veterinarians to run an ELISA with animal specimens, it is not an IVD per definition by the IVDR. However, if the analyzer is intended to perform and analyze one or more specific enzyme immunoassays, the requirements for Rule 5b are met and you indeed have developed an in vitro diagnostic medical device (MDCG 2020-16).
We recommend three steps to make sure, that your device is an in vitro diagnostic medical device:
Step 1: Compose the intended purpose of your device with great care. Describe exactly to which specific IVD examination(s) your device is relating. To include every relevant aspect, use IVDR Annex I, 20.4.1 c) as a checklist for the intended purpose.
Step 2: Check if your device is intended for a medical purpose, such as the diagnosis of a disease or injury of a human being. Use the MDR definition for ‘medical devices’ (MDR, Article 2 ‘Definitions’) and the IVDR definition for ‘in vitro diagnostic medical devices’ (IVDR, Article 2 ‘Definitions’). Regardless of whether it is a PCR cycler, ELISA analyzer or sequencer: if your device is intended for the examination of specimens from the human body but without a specific IVD application, your device is “only” for general laboratory use and not an in vitro diagnostic medical device. Your device definitively has a medical purpose, if you can prove that its use results in diagnostic information for an individual patient.
Step 3: Make sure, that your device is used to examine specimens derived from the human body. If you can think of your device being used by laboratories conducting veterinary diagnostics or environmental or food analysis, go back to your intended purpose and refine it.
Any uncertainties and ambiguities in the classification of your device result from the intended purpose being incomplete or vaguely drafted. So, prepare the intended purpose of your device with great care! The intended purpose is the foundation on which your Technical Documentation (your house) is built. If it shakes, it will not only be very difficult to build the house, but also to keep it stable during use and prevent it from collapsing. In contrast, you will greatly benefit from a precisely formulated intended purpose. The clearer you are about what claims you want to prove, the easier it will be for you to create your documents (performance evaluation, literature search strategy, PMS documents). So, take a step back and check the intended purpose critically. You and your device will benefit greatly from this!
This article was written by Dr. Carmen Peeß, AstraCon GmbH.