The Medical Device Regulation (EU) 2017/745, also referred to as MDR, replaces the EU Medical Device Directive (MDD, 93/42/EEC). MDR requirements are stricter than its predecessor MDD requirements and pursue the main goal to ensure safety and performance of medical devices manufactured and sold in the EU.
Since the introduction of MDR in 2017, our team has been working towards fulfilling all new criteria. It has been a challenging task and hard work during the last years, but in the end it has helped us as a company to improve our internal processes, and our quality management system in particular.
The MDR certification is an important milestone for us, and we are very happy to have achieved this step in 2022.