HARTMANN: a MDR pioneer
MDR was created to improve the safety, traceability and transparency of medical devices in all EU countries. As of May 26, 2021, MDR applies for all partners involved in healthcare. It marks an important step that will result in improved transparency and traceability of all medical devices and in greater patient safety.
New regulations also mean changes in procurement processes, in documentation and also in the products used, which could result in product delivery delays or even cancellations. Not at HARTMANN, however.
HARTMANN is one of very few companies in the market with a clear MDR action plan that we have been following for years. In addition, we work closely with our key Notified Body TÜV SÜD. We can already: We are "MDR ready".
How do I know if a product is MDR compliant?
This is the question most healthcare partners are asking. Other questions you should be asking your suppliers and manufacturers:
- Do you have a Notified Body accredited under MDR?
- Do you have a date for certification?
- Are you already MDR certified?
- Have you already declared the conformity of the products according to MDR?
You should only be buying medical devices from sources who can give a resounding yes to all four questions. HARTMANN, of course, is one of the few suppliers who can answer positively and whose products already bear the MD symbol.
