Visit from the Danish Medicines Agency

1. March 2023

Wolturnus has had a visit from the Danish Medicines Agency to review our systems and practices for compliance with the new Medical Device Regulation (MDR).

And we’re happy to inform you that we passed with flying colors – or with the finest result possible, which is that Wolturnus ‘generally comply with the legislation’.

The MDR is a set of regulations that Wolturnus, a Class 1 medical device manufacturer, must comply with to sell our products in European markets. This means, for instance, better quality control, more documentation and better labelling.

An investment in safety
Since the MDR came into force, Wolturnus has invested approximately DKK 1.9 million in ensuring the necessary documentation and practices. We have

  • reclassified our products,
  • updated our quality management system, documentation for compliance with General Safety and Performance Requirements as well as technical documentation,
  • reviewed our risk management system and our post-market surveillance system
  • and we have assigned UDI numbers for all our products.

It may seem like a lot of money but it’s well spent as it is an investment in ensuring our customers, users and partners feel safe when they do business with us. After all, the MDR Regulation helps increase patient safety and provides uniform standards for developing and producing medical devices.

The visit from the Danish Medicines Agency was both an educational and positive experience, confiming that the resources we have allocated to comply with the MDR are well spent.

Quality and sustainability
Fundamentally, we do our utmost every day to create peace of mind for our customers, users and partners, including having well-trained and experienced sales consultants, accessible customer service and, not least, having both security and paperwork in order.

Thank you to Inspector Sofie Thørholm from the Danish Medicines Agency for her sincere interest in Wolturnus and not least for her good input on how we can optimise our efforts in the MDR area in the future.