Whether you are a distributor of medical devices, a manager or purchaser ensuring all your products live up to current regulations, or a nurse using medical devices in your daily work, here is what you need to know about MDR.
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, 2021.
The new Medical Device Regulation (2017/745/EU) (MDR) adopted in May 2017, will replace the existing Medical Device Directive (93/42/EEC) (MDD).
In many ways, MDR is the natural progression of MDD in terms of ensuring patient safety in a modern world, but is not a one-to-one change.
MDR is an entirely new set of regulations that governs the production and distribution of medical devices in Europe and is mandatory for medical device companies that want to sell products in Europe.
MDD has been in existence since 1993, and it’s safe to say a lot has changed in those nearly 30 years: demographics of the population, use of technology and software in health care, and general production and supply methods, to name a few.
A few of the most important changes that will ensure transparency and patient safety include: