SDI Limited secures EU MDR certification

SDI Limited (ASX: $SDI) has successfully secured its certification under the European Union's Medical Device Regulation 2017/745 (MDR) as a manufacturer. This certification allows SDI to continue selling existing products into all European markets as planned and without interruption under the EU MDR Transition Extension. Additionally, the certification includes MDR product certification of SDI's latest new product, Stela, which is now registered in most of SDI's key markets.

SDI's CEO on EU MDR certification

The EU MDR represents a significant enhancement over the previous Medical Device Directive (MDD), emphasising improved safety measures, risk management, post-market surveillance, and data collection for medical devices. This milestone is a testament to the collaborative efforts of the team at SDI, underscoring our continued commitment to the quality, safety, and effectiveness of our products. The MDR certification marks a pivotal step in SDI's ongoing expansion within the European market, supporting growth through both existing and new products. Europe is SDI's largest market, and the launch is planned for July. Stela will become SDI's largest Composite product, and the opportunities are significant.

SDI's EU MDR certification and future outlook

SDI Limited (ASX: $SDI) has successfully secured its certification under the European Union's Medical Device Regulation 2017/745 (MDR) as a manufacturer, allowing the company to continue selling existing products into all European markets as planned and without interruption. The certification also includes MDR product certification of SDI's latest new product, Stela, which is now registered in most of SDI's key markets. SDI's CEO, Samantha Cheetham, highlighted the significance of the EU MDR, emphasizing improved safety measures, risk management, post-market surveillance, and data collection for medical devices. The company sees this certification as a pivotal step in its ongoing expansion within the European market, supporting growth through both existing and new products. With Europe being SDI's largest market, the launch of Stela in July is anticipated to be a significant opportunity for the company's Composite product line.