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European Medical Device Regulation: Collaboration to Drive Innovation

January 20, 2020

Europe, the second largest global medtech market, is enduring a major overhaul as two brand new regulations for medical devices and in-vitro diagnostics will soon replace previous legislation. By May 26, 2020, more complex rules will impact the daily work of manufacturers, health professionals and institutions as well as the public. Complying with the new Medical Device Regulation seems overwhelming and many don’t know where to start. This paper “European Medical Device Regulation: Collaboration to Drive Innovation”, discusses the key changes and best practices for a successful transition to the new legislative framework.

Authored by Dr. Monica Tocchi, founder and Chief Medical Officer at Meditrial, the white paper offers a strategic perspective on the implications of the changes in the context of the medtech innovation community and outlines key areas for the relevant actors. The author provides essential information in a clear style, with original infographics and tips to get ready. The publication comes at a time when the application date is rapidly approaching but many questions remain unanswered and adjustments to current regulatory practices are becoming a necessity during the transition period.

Nevertheless, the challenge of mastering the new requirements and significant costs involved with the MDR transition are forcing companies to seek expanded collaborations and broader partnerships in order to change together and adjust to the new scenario. Part of the answer to these problems will come from initiatives to streamline the process, along with the application of digital technologies to increase efficiency.

KEY TAKEAWAYS

  1. Europe, the second largest global medtech market, is enduring a major overhaul due to deep changes in regulation on May 26, 2020.
  2. Complex new rules will impact the daily work of economic operators, healthcare professionals and health institutions.
  3. Industry is adopting smarter models of cross-functional collaboration and digital transformative tools for agility, competitiveness and sustained success.

TIPS TO GET READY

If you are involved with the MDR transition strategy, gap assessments, or simply getting up to speed quickly on the MDR requirements, start by learning the regulation firsthand by identifying suitable training for key people in your organization. The knowledge gained will allow you to asses the impact on your organization and the appropriate next steps to meet the new requirements for all members of the supply chain, health institutions and healthcare professionals.

Rely on regulatory experts, who have assisted multiple medical device companies with QA/RA compliance, to address all of your questions and help you organize a specific transition strategy for your company based on your product range, certification cycle, and markets you serve. Gain the competence needed to interact effectively with your Notified Body. Expert consulting groups may provide a headstart and accelerate your transition, reducing business risk and enabling success.

MEDITRIAL CAN HELP

Meditrial is a trusted consulting company and European representative.

Meditrial also provides strategic advice and support for regulatory compliance and quality management system upgrade including digital tranformative options.

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