Regulatory Approval

The European Union Medical Device Regulation (EU MDR) has significantly reshaped the regulatory landscape for medical device manufacturers across the EU, including the Netherlands. Whether you’re a startup introducing your first product or an established manufacturer updating your portfolio, understanding and complying with the EU MDR is critical for accessing and staying in the European market. What […]

Introduction CE Marking is a mandatory conformity mark for medical devices sold in the European Economic Area (EEA). It signifies that your product complies with the EU Medical Device Regulation (EU MDR 2017/745). If you’re a medical device manufacturer looking to access the European market, obtaining CE Marking is a critical step. In this blog,