Medical Device Regulation (MDR) to be postponed
The Medical Device Regulation (MDR) – which was due to enter into force in May this year –will replace the Medical Device Directive in Europe and is much more stringent. However, MDR is now postponed until May 2021.
At the beginning of April, there was considerable concern that the introduction of the regulation would aggravate the shortages of personal protective equipment and other medical devices needed to fight coronavirus. The EU parliament has now agreed to postpone the MDR deadline by a year to allow authorities and the industry to prioritise their efforts towards COVID-19.
As Mölnlycke has a very good momentum in the MDR transition program , we will continue with the original schedule. With our products being made ready for MDR, we can be certain of being able to continue serving our customers with the vital medical devices they need long into the future.
Wide-reaching reforms will drive patient safety
The MDR reforms are wide-reaching. There are enhanced requirements on the safety and reliability of medical devices, with more emphasis on a life cycle approach, backed by clinical data, as well as increased post-market surveillance. National Competent Authorities and the EU Commission will have a stronger control and monitoring role. There are also added requirements that will strengthen transparency and information for users.
The regulation will improve patient safety by evaluating existing devices more fully and ensuring transparency once they are introduced to the market. It is costly to implement and requires every medical device to have upgraded technical documentation. As a result, there are predictions that many existing devices from all companies will not remain on the market.
The outcome in the long run will be a stronger, more accountable medtech industry that favours responsible businesses like Mölnlycke which take a company-wide approach to compliance.