When the European Medical Device Regulation (MDR) goes into effect on May 26th, 2020, you can rest assured continuing use of your regular ABENA products.
The products are the same, but since 2017, we have been working behind the scenes, making sure all medical devices live up to the new requirements for transparency and documentation.
MDR is meant to ensure patient safety thanks to the high standards for transparency, documentation, tracking, and feedback loops. Regulating medical devices is nothing new. Since 1993, MDD (the Medical Device Directive) has been the governing body for safety and efficacy of medical devices in Europe.
With more than 500,000 types of medical devices on the EU market, safety regulations for medical devices affects millions of users all over Europe. With the onset of MDR, European legislation and medical devices now live up to the latest advances in science, technology, and product safety.
MDR is for your safety. The rules have been strengthened and reevaluated to protect the users of medical devices through increased transparency throughout the value chain.
A few of the most important changes that will ensure transparency and patient safety include:
Because we care, patient safety has been an integrated part of ABENA’s culture in the nearly 50 years we have been in the health care sector. From working actively with MDD since 1993, we have the experience to confidently say we are ready for MDR to step into full effect on May 26, 2020.
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