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EU MDR and beyond: The balancing act between innovation and compliance

Posted 01 May 2021 | By Annemein Pullen, PhD 

EU MDR and beyond: The balancing act between innovation and compliance

We have entered a new era of continuous global regulatory change. As the new EU Medical Device Regulation (MDR) brings significant requirements for technical documentation, clinical data, quality management systems and more, experts predict that approximately 30% of companies may go out of business.

Device manufacturers, especially those that have grown through acquisition, can have decades worth of legacy documents, processes, and systems, and may struggle to keep up with the constant traceability and transparency that the new regulation stipulates.

Forward-thinking companies see the new regulation as an opportunity to harmonize and modernize processes and technology to gain market advantage.

Alcon, a leading ophthalmology devices manufacturer, used to handle submissions and registrations manually, using spreadsheets and email. If Alcon had a technical document that supported five technical files, they had to have five versions of that technical file in the system. Now, Alcon has replaced their outdated, siloed systems with a unified and connected cloud platform to manage all regulatory content and data from one system.

Lori Holder, director of global regulatory operations at Alcon, remarks, “With our unified approach, all that data is contained in one system. We can take that information and upload templates, request funding, and completely manage submissions without emailing back and forth. We are also able to collaborate on final drafts of submissions and submit them for approval electronically.”

This white paper examines challenges and opportunities that arise post the Date of Application (DoA), and outlines business areas for improvement to ensure long-term compliance, including:
  • Addressing MDR influence on medtech innovation capabilities
  • Driving operational modernization within the business
  • Achieving unified and connected regulatory environments
  • Managing compliance: examples of modern approaches from leading device companies
Download the white paper now to ensure your medtech business is set to balance innovation and compliance to reach MDR success.

Annemein Pullen, PhD, is Senior Director, Medtech Strategy, Europe at Veeva  


© 2021 Regulatory Affairs Professionals Society.
This article is sponsored and does not reflect the views or opinions of RAPS. The sponsor is solely responsible for the content presented.

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