May 24 2022
MDR Grace Period ends May 26th 2024. As this date approaches, manufacturers are requested to focus even more closely on how to plan transition for the legacy devices in their portfolio.
For MDD to MDR transitions manufacturers are asking themselves:
“Are we prepared for re-certification according to MDR?”
“Do we have sufficient clinical data for this re-certification?”
“Do we have robuste clinical data to support device claims?”
With MDR, the General Safety and Performance Requirements need to be supported by clinical evidence. What at first sight looks like a rather simple renewal of certificate becomes a demanding re-certification with the troubling uncertainty that available clinical data may turn out to be insufficient for the purpose.
Time is short, resources at Notified Bodies are increasingly booked up, and waiting is not the answer.
To support all medical device manufacturers in a successful transition, 1MED introduces a brand-new service for fast-track clinical data assessment for MDR recertification able to systematically analyze data, early identify gaps, propose solutions and action plans.
Discovery Pack is 1MED’s brand new, fast, reliable and affordable service supporting manufacturers in MDR transition.
Interested in receiving more information?
Fill out the form to receive the service brochure or schedule a call with our medical device experts