On September 7th, 2022, a first version of the EU manual on Borderline and Classification for medical devices under the MDR and IVDR has been released. Additional cases will be populated when their review is completed under the so-called ‘Helsinki Procedure’ involving national competent authorities and the MDCG
This manual records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR). It is important to note that many sections still need to be populated when cases are finalised under the Helsinki Procedure.
Borderline cases of interest that are already included:
1) Classification of Medical Devices
a. Dermal filler ‘implantable’
Dermal fillers that are intended to compensate fat loss, e.g. in HIV infected patients with severe lipoatrophy, caused by the highly active antiretroviral therapy and where the result of this injection of dermal fillers is the modification of anatomy are considered implantable Medical Devices.
These dermal fillers, which are wholly or mainly absorbed, are covered by rules 7 and 8 of Annex VIII of the MDR, depending on the intended duration of use. As they are administered by injection, and this is considered a clinical intervention, they fulfil the definition of an implantable device, according to Article 2(5) of the MDR.
2) Borderline between IVDs and Medical Devices
a. FeNO measuring device
Such a measuring device is composed of different parts. The instrument and breathing handle are regarded as in vitro diagnostic medical devices, but the disposable filter (viral and bacterial) that has to be changed for each new measurement session and for each patient would be a class I medical device according to Regulation (EU) 2017/745.
Since the exhaled air is no longer part of the human body, the exhaled air is considered to be a gaseous specimen derived from the human body, which is subsequently analysed by a device outside of the body. The device provides information for a medical purpose concerning a physiological or pathological state, which would qualify this product as an in vitro diagnostic medical device according to the Regulation (EU) 2017/746.
Since the principal intended purpose of the product is to be used for the examination of specimens derived from the human body for the purposes of providing information, according to the definition in Article 2(1) of the Regulation (EU) 2017/746, it is qualified as an in vitro diagnostic medical device.
What does this mean to you?
Once exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) have been finalized, this manual will serve as a support tool for the classification of borderline cases for IVD manufacturers.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.