Last month QMD Services GmbH was designated a Notified Body under Regulation 2017/746 on in-vitro diagnostic medical devices (the IVDR). This makes it the eighth Notified Body, and Austria’s first, to have received a designation from the European Commission for these purposes.
Notified Bodies play a pivotal role in assessing the conformity of in vitro diagnostic medical devices against the requirements of the IVDR. With the exception of low-risk non-sterile Class A devices, all manufacturers must obtain certification from an EU Notified Body before placing their products on the EU market.
However, QMD Services is not permitted to assess all categories of IVD devices. Instead, its scope is limited to the following product families (as specified in its notification):
- Devices intended to be used for markers of cancer and non-malignant tumours,
- Devices intended to be used for human genetic testing,
- Devices intended to be used to determine markers of infections/immune status,
- Devices intended to be used for non-infectious pathologies, physiological markers, disorders or impairments (except those for human genetic testing), and therapeutic measures.
QMD Services has, therefore, not been designated as competent to assess:
- Devices intended to be used to determine specific blood markers (e.g. ABO system markers) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs for transfusion, transplantation or cell administration,
- Devices intended to be used for other blood grouping (e.g MNS, Lewis),
- Devices intended to be used for tissue typing (e.g. for typing, cross-matching, relevant software, genetic screening etc.),
- Controls without a quantitative or qualitative assigned value, and
- Class A devices in sterile condition.
It is hoped that the designation of QMD Services will increase the EU’s capacity to process conformity assessments for IVD devices. QMD Services now joins seven other existing Notified Bodies which are able to carry out assessments under the IVDR. This includes three organisations in Germany, two in the Netherlands, one in France and one in Slovakia.
While the designation of QMD Services is certainly a welcome step towards addressing Notified Body capacity issues in the EU, there is still undoubtedly room for improvement. Last month, the Commission proposed removing the “sell off” provision in Article 110(4) IVDR which currently allows devices certified under the old Directive-based regime to be placed on the market only up until 27th May 2025. After this date, such devices may no longer be distributed within the EU (either by the manufacturer or any party other than the final end user).
By removing this provision, the Commission hopes to ease some of the pressure experienced by Notified Bodies as the deadline for the full implementation of the IVDR approaches. Thus, it is clear that addressing Notified Body capacity remains a priority in the EU and that we can expect to continue seeing new IVDR designations in the future. According to the Commission, there are currently ten applications for designation in progress, two of which are in an advanced stage.
We are keeping a close eye on future EU Notified Body appointments, so follow our blog to stay current with recent developments!
