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.
You don't have to know everything about MDR - because we do
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.
MDR – what and why?
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.
What’s new in MDR?
A few of the most important changes that ensure transparency and patient safety include:
- Increased documentation: To make sure products are safe to use, documentation and risk analysis plays an increased role in MDR.
- Stronger feedback loops: The increased focus on documentation also requires manufacturers, importers and distributers to actively listen and react to consumer and customer feedback. Processes must be in place to actively take feedback and complaints into account when reevaluating a products function.
- Improved tracking of products throughout the entire lifecycle, from manufacturer to end-user. MDR promotes a lifecycle approach to medical device regulation rather than just getting a product to market. The EUDAMED database, used for tracking products throughout the value chain from manufacturer to end-user, has been updated. It includes stronger requirements for documentation and transparency, including optimized processes for when products are recalled.
