New Medical Device Regulation (MDR) comes into application

Today, the new Medical Device Regulation (MDR) replaces the former Medical Device Directive (MDD).

MDR is a new set of regulations that we as a Class 1 medical device manufacturer has to comply with to sell our products in European markets. This means for instance better quality control, more documentation, better labelling and are intended to improve the safety and performance of medical devices.

For the past two years, we have been working to be ready to comply with the new regulations. We have reclassified our products, updated our quality management system, documentation for compliance with General Safety and Performance Requirements, technical documentation, risk management system and our post-market surveillance system. We have also updated our distributor agreements, user manuals and assigned UDI numbers for the products and appointed a Person Responsible for Regulatory Compliance.

We couldn’t have done it without our talented Quality Assurance Manager, Tina, who has been taking all precautionary measures so we could be ready for this day.

In case you have any questions, you are very welcome to contact our Quality Assurance Manager, Tina Jensen, on tel. +45 92 15 25 87 or email