MDR certification for the therapeutic deep heat device Calopad®: An important milestone

We are proud to announce that our therapeutic deep heat device Calopad® has received MDR (Medical Device Regulation) certification. This certification ensures that our product meets the strict requirements of the European Union for medical devices – a significant step for our company and, most importantly, for the safety and quality we want to provide to our customers. 

What is MDR? And how does it differ from MDD?

The MDR (Medical Device Regulation) is the medical device regulation of the European Union, which has been mandatory for all medical device manufacturers since 2021. It sets high standards for the quality and safety of products marketed as medical devices. The MDR ensures that only products that have undergone rigorous testing and are both safe and effective are approved. The MDR is an updated version of the previous MDD (Medical Devices Directive).

The MDD mainly focused on ensuring that a product was safe, worked well, and met the necessary requirements for market approval. In contrast, the MDR considers the entire lifecycle of a medical device – from development to testing, manufacturing, marketing, safety, effectiveness, and long-term use.

What is a medical device? 

A medical device is an instrument, apparatus, or other material used for medical purposes. This includes the diagnosis, prevention, monitoring, or treatment of diseases. The therapeutic deep heat device Calopad® falls into this category as it is used for targeted heat therapy to relieve pain – whether it be menstrual pain, muscle tension, or to support faster recovery.

Why is MDR certification so important to us? 

The MDR certification is more than just a formal step for us – it confirms that we offer a product that meets the highest standards of quality and safety. Our customers need to be able to trust that the therapeutic deep heat device Calopad® is safe and delivers the promised results. For us, the certification is also a crucial step towards being successful in the European market and gaining the trust of our customers. 

The certification process was long, time-consuming, and costly, and it is not something that we, as a start-up, take for granted. We would like to thank all partners and experts who have supported us along the way. Special thanks go to Stefano Adami and Silvia Scolari, Senior Consultant Medical Devices at Confinis, and to Patrick Degelo, Chief Technical Officer at Calopad®.