A source of information for O&P Professionals
The aim of the new EU-wide and uniform regulations is to ensure patient safety and to enhance the quality of medical devices on the European market for the benefit of all. Manufacturers in particular are facing major challenges, as the implementation of the new requirements involves high effort and costs. The extent to which the changes arising from those regulatory replacement affects your business depends on the role you hold.
This website focuses on the new Medical Device Regulation 2017/745 (MDR) for manufacturers of custom-made devices. This new Medical Device Regulation 2017/745 (MDR) will play a significant role of patient care providers that create products like prosthetics, orthotics or wheelchairs. Creating prosthesis or orthosis is patient specific and therefore requires special documents which this website can help provide as information or as a template. This website will not take over your responsibility or liability, but we can offer support to be compliant to the Medical Device Regulation 2017/745 (MDR).