The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
The challenges will continue to keep medtech manufacturers and other stakeholders in the healthcare industry on their toes.
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
Trends that push boundaries and shake up medical device security.
Reduce risk and control your label, its design, and the data.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
It is time to extend AI’s use into labor & delivery departments, where the technology can help guide care teams to mitigate risks and make informed decisions.
When outsourcing these key functions, asking the right questions will help minimize the risk.
How manufacturers can better understand their customers in a rapidly changing provider environment.