NanoGroup subsidiary NanoSanguis S.A. has entered into a cooperation agreement with notified body TÜV NORD Polska sp. z o.o. The agreement formally initiates the medical device certification process for the NanOX Recovery Box in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR).

The agreement marks the achievement of the first milestone announced in autumn 2025 and represents a significant stage in the development of NanoGroup’s projects, bringing them closer to commercialisation in the European Union and in non-EU markets that recognise CE marking.

Scope of Certification and MDR Regulations

The agreement covers a comprehensive certification process to be carried out by TÜV NORD Polska, including certification of the quality management system in accordance with the PN-EN ISO 13485 standard and the issuance of CE certificates confirming compliance with MDR requirements.

The certification process applies to the components of the NanOX System comprising the NanOX Recovery Box mechanical organ perfusion device and the single-use NanOX 4K Perfusion Set. These products have been classified as Class IIa and Class IIb medical devices, respectively, for which MDR requires conformity assessment by an independent notified body.

TÜV NORD Polska sp. z o.o., which holds a notification issued by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), is authorised to conduct this type of conformity assessment.

NanOX Technology and the Uniqueness of the Solution

The NanOX Recovery Box is an innovative solution for ex vivo kidney perfusion, enabling long-term preservation and monitoring across the full range of temperatures – from hypothermic and subnormothermic perfusion to normothermic perfusion.

Ultimately, the system will be complemented by NanOX 4 Kidney, the perfusion fluid under development that carries respiratory gases. This will make it possible to create the world’s first complete, dedicated system for normothermic kidney perfusion.

The Certification Process

As part of the certification process, TÜV NORD Polska will assess key processes affecting the final product, including design and development, manufacturing, quality control, and the completeness of technical documentation and clinical data.

Following the successful attainment of MDR and ISO 13485 certificates, cooperation will continue through surveillance audits in accordance with applicable regulatory requirements.

Certification as Part of the Development Strategy

Obtaining MDR and ISO 13485 certificates will enable NanoGroup S.A. to introduce its products to markets across the European Union and to non-EU countries that recognise CE marking. This will provide international confirmation of the safety, quality and performance of the devices and constitute a prerequisite for their full commercialisation.

These activities form part of NanoGroup S.A.’s long-term strategy, which involves developing breakthrough technologies in normothermic organ perfusion, diversifying its project portfolio and building a broad portfolio of innovative biotechnology ventures with significant commercial and partnering potential.