Handicare´s transition towards compliance with the new EU Medical Device Regulation (MDR)

On May 26, 2021, the new European Medical Device Regulation (MDR), approved by the European Council and Parlament, will come into effect. This was earlier set to May 26, 2020, but postponed due to the COVID-19 situation.

These regulations will have an impact upon all economic operators involved in the medical device business. The new MDR bring EU legislation into line with technical advances, changes in medical science, and progress in law-making.

The new regulations will create a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers, an improved regulation that we at Handicare welcome.

Handicare has launched an extensive and proactive effort to implement and adapt to the new regulations throughout our organization including all our medical products on the market.

The transition will be completed in due time prior to the regulation comes into effect.

Read more about the new MDR here