Piomic receives certification under MDR, the new European Medical Device Regulation
Piomic Medical has received certificates according to MDR for its Class IIa and Class Is medical devices of the COMS® One Therapy System.
Zurich, Switzerland – 27 April 2023 – Piomic Medical at the forefront of innovation in the treatment of hard-to-heal wounds, today announces it has received certificates according to Medical Device Regulation (MDR) from its Notified Body, TÜV SÜD, ensuring continuous market access in the European Union (EU). The COMS One® therapy system is estimated to be within the first 10% of medical devices to be certified according to MDR.
Piomic 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 COMS® One therapy system are compliant with the latest regulatory standards required for medical devices in Europe. This announcement follows the recent unconditional FDA IDE approval for the MAVERICKS U.S. pivotal trial, demonstrating Piomic Medical’s compliance with the high standards of medical device regulations internationally.
Adrian Meier, Head of Quality and Regulatory at Piomic Medical, commented: “Achieving MDR certification is another major milestone and the result of our early adaptation strategy formed in 2019 to the new and more stringent regulatory requirements in Europe. Considering the actual situation, where many medical device companies still struggle to implement the new requirements, this achievement would not have been possible without the extensive and diligent work of the entire Piomic Medical team. According to EU commission information, in October 2022 approximately 10% of the existing certificates were transferred to MDR. Consequently, the transitional provisions were again extended in March 2023. We are very thankful for the opportunity to become a new customer of TÜV SÜD, our competent Notified Body and we look forward to continuing working with them.”
Christopher Hertz, Chief Executive Officer at Piomic Medical, added: “Without doubt, MDR has raised the standards for medical device regulation, and we are excited to be among the first Class II active 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 in meeting the standards required for approval of the COMS® One therapy system in the U.S.”
About European Medical Device Regulation (MDR)
The MDR 2017/745 came into effect in April 2017, 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.
Important Regulatory Disclaimers
The COMS® One therapy system has not yet received regulatory approval in the U.S. and Canada. As such, use is limited to investigational use only in the U.S. Any statement in this press release about the safety and effectiveness of the system does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these geographies.