Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI), ensuring continuous market access of the alfapump system in the European Union (EU).
Sequana Medical was granted the EU Quality Management System (QMS) Certificate and the EU Technical Documentation Assessment Certificate confirming that the Company’s QMS and the alfapump system are compliant with the latest regulatory standards required for medical devices in Europe. The Company’s proprietary DirectLink technology built into the alfapump system has been classified as medical device under the MDR, clearly demonstrating the relevance and importance of alfapump performance data monitoring, allowing physicians to closer follow-up on their patients. This announcement follows the recent QMS certification under the Medical Device Single Audit Program (MDSAP), demonstrating Sequana Medical’s compliance to the high standards of medical device regulations internationally.
Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: “Achieving MDR certification is another major milestone and the result of our early adaption to the new and more stringent regulatory requirements in Europe. This achievement would not have been possible without the extensive and diligent work of the entire Sequana Medical team. We are also very thankful for the longstanding relationship with BSI, our competent Notified Body, and we look forward to continuing working with them.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “Without doubt, MDR has raised the standards for medical device regulation and we are excited to be one of the first novel Class III active implantable medical device companies to receive this certification. It shows our strong commitment to complying with the highest regulatory standards for medical devices and is a demonstration of our progress to meeting the standards required for approval of the alfapump in the U.S.”
About European Medical Device Regulation (MDR)
The MDR 2017/745 came into effect in May 2021, replacing the former European Directives for medical devices (AIMDD 90/385/EEC and MDD 93/42/EEC). It is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of safety and health whilst supporting innovation. MDR has significantly increased the requirements in respect of technical documentation, benefit-risk evaluation, Unique Device Identification (UDI), Economic Operators, clinical data and post-market surveillance, with more stringent scrutiny of Competent Authorities and Notified Bodies. It represents the biggest change in European medical device compliance standards in more than 20 years.