The new Medical Device Regulation enters into full application2021-06-28
The EU’s new Medical Device Regulation (MDR) 2017/745 finally came into full application on the 26th of May, 2021, following a year’s delay due to the COVID-19 pandemic and replacing the earlier Medical Devices Directive. The MDR seeks to ensure a high level of public health and patient safety taking into account scientific progress and brings forward a set of new standards and requirements which products must comply with.
Now Ortho Baltic assures that in the scope of the custom-made production services of orthopaedic devices that Ortho Baltic provides for its customers (certain production stages of orthopaedic footwear and/or orthoses), they are being carried out and documented (manufacturing processes, materials, quality management, etc.) in accordance with the new EU MDR.
At the same time, products sold under our own brands like Easy Walk® line of pre-preg orthoses meet all new requirements imposed us as a manufacturer.
However, implementation efforts will not stop at the date of application and are continued by further improvements.Back