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, MDR will influence all aspects of the health-care sector.
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, to stepping into MDR in 2021 and carrying on with the same high standard of patient safety that is in compliance with current regulations.
The new Medical Device Regulation (2017/745/EU) (MDR) adopted in May 2017, has replaced the earlier 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 manufacture and sell products in Europe.
MDD has existed 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. An update was needed, and this is where MDR comes in.
A few of the most important changes that ensure transparency and patient safety include: