Ask the Expert: EU MDR • Generis

HCL hosted a Lunch & Learn Roundtable Discussion at the American Medical Device Summit 2018 last month in Chicago, IL. The session, “Ask the Expert – MDR and Lifecycle Management”, was led by Associate Vice President, Hilde Viroux. Hilde addressed questions surrounding the uncertainty of EUDAMED and UDI, the transition period, and how to obtain compliance.

This is an excerpt from an interview Generis Group did with Hilde Viroux, AVP, Regulatory of HCL, America Inc. prior to the American Medical Device Summit 2018.

“What are some of the biggest challenges in the new MDR that will impact device manufacturers?

There are a lot of changes in the EU MDR that impact device manufacturers. Generating clinical data for all devices, developing the required reports and updating technical files to be compliant with Annex II and III is where most of the budget will typically go. In addition, there is the requirement to trace hazardous substances in devices and identify them on the label. The new regulation also requires manufacturers to set up a proactive approach to following the performance and safety of the device throughout its lifecycle.”

Questions discussed:

• What are some of the biggest changes in the new MDR that will impact device manufacturers?
• What are some of the specific requirements medical device manufacturers will need to start preparing for?
• What challenges will medical device manufacturing companies face if they delay their preparations?
• How do EUDAMED and UDI fit into the new regulations?
• How will MDR affect small and mid-sized companies? What do these companies need to do to ensure a smooth and successful transition?
• How can HCL help medical device manufacturing companies through MDR transition and implementation?
• What advice would you give to growing medical device companies looking to navigate the ever-increasing compliance landscape?

Click through to access the full interview here.