The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic.
According to the European Commission, the Medical Devices Regulation (MDR) seeks to ensure a high level of public health and patient safety taking into account scientific progress.
The regulation entered into force in May 2017, replacing the Medical Devices...
Just 27% of 230 medical device makers surveyed expect to be in full compliance with the European Union’s Medical Device Regulation (MDR), which goes into effect in May next year, a study has found.
The Regulatory Affairs Professionals Society (RAPS) and US tax, audit and advisory firm KPMG surveyed companies internationally, with 91% of participants from the EU and North America.
Of those...
