EC CERTIFICATE received from TUV SUD – new validity 2024

The industry of medical devices is subject to a wide range of regulations whose scope is to raise the quality and safety of the products before placing them in the market.

Next month, May 2021, the European Medical Device Regulation 2017/45 (MDR) will replace the MDD 93/42/EEC as well as the  MDD 90/385/EEC -This will notably cause major changes for every manufacturers who want to obtain access to the European market. During the so called transition phase, HPF has worked very hard to get ready for this healthcare milestone.

As a result, starting from April 30,2020,  HPF is certified ISO13485 and MDD 93/ 42 with TUV SUD – one of the world’s leading independent Notified Body that is  particularly appreciated by the numerous operators of the medical sector.

In consideration of the MDR’s increasing requirements, for our next certification step, we chose TUV SUD in order enter into the MDR new era being assessed by such a renowned institution.