Today we are excited to announce that INDIBA recently received MDR approval, allowing it to continue positioning all its medical devices and products on the European market.
What is MDR, and why does it matter?
The Medical Device Regulation (MDR), adopted in April 2017, changed the European legal framework for medical devices and introduced new principles and support responsibilities for EMA and competent national authorities in the assessment of specific categories of products. Achieving MDR approval means that INDIBA has met the necessary regulatory requirements for placing its devices on the EU medical device market.
Gaining this approval involved the re-assessment and assessment of many of INDIBA’s medical device products by the relevant authorities, as well as putting in a range of new policies around devices that meant they complied with these new standards. In addition, obtaining this approval has only been possible thanks to extensive clinical investigation into our products’ safety, efficacy, and reliability, which we take very seriously.
As we are sure you can appreciate, this process has been a considerable undertaking. Yet, we are pleased to say that INDIBA has been patient and meticulous in ensuring it follows every rule and regulation. Furthermore, thanks to INDIBA’s prudence, it is one of the first companies to attain this approval (the deadline for assessment is May 2024), putting it ahead of many of our competitor businesses.
MDR approval represents another outstanding milestone for INDIBA that will help it to excel in the future and reach yet more ambitious goals.
INDIBA is a global leader in Radiofrequency (RF) solutions for the physiotherapy, aesthetic, and veterinary markets. The company is known globally for its scientific research performed in the last 35 years and the incredible range of treatments that this research has enhanced and enabled.