Medical devices
The global medical device industry faces growing pressure to demonstrate not just safety and quality, but also data transparency, lifecycle accountability, and sustainability.
In the EU, the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) establish a new legal framework for how medical devices are manufactured, registered, and monitored across the European market. These laws apply to manufacturers, importers, distributors, and authorized representatives placing medical or diagnostic devices on the EU market from small suppliers of surgical instruments to large multinational device producers.
The MDR and IVDR aim to ensure that every product can be traced from production to patient use, strengthening both patient safety and supply chain transparency.
They also link to wider sustainability goals under the EU Green Deal and Corporate Sustainability Reporting Directive (CSRD), as accurate product data becomes critical for ESG reporting and circularity tracking.
On osapeers, compliance and sustainability professionals collaborate to:
- Understand how digital traceability and unique device identification (UDI) improve risk management and ESG metrics.
- Share experiences implementing regulatory data exchange through EUDAMED and GUDID.
- Connect MedTech companies, hospitals, and suppliers in a community focused on interoperable and sustainable healthcare systems.
