Your Guide to EU MDR Compliance

September 12, 2018

By Sparta Systems Editorial

 

New Rules Require Greater Traceability, Data Transparency

By: Sandra K. Rodriguez, Market Analyst at Axendia

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry.  Gaining CE Mark of approval to market and place devices into service will require a complete overhaul.  EU MDR consists of 10 chapters and 97 articles spanning Design, Manufacturer Obligations, Evidence Collection, Conformity Assessment, Registration, Post Market Surveillance and Vigilance.

These new rules will apply to some previously unregulated products and there will be no grandfathering of previously approved medical devices.  As a result, tighter controls will be imposed on medical device sales throughout the EU.  Controls on notified bodies that can approve the marketing of medical devices and the reporting on clinical trials will also be tightened.  Once devices are available for use on the market, manufacturers will be obligated to collect performance data to support tighter post-market surveillance requirements.  In addition, a new system will apply to in vitro diagnostic medical devices.

As concerns quickly mounted throughout the industry, we interviewed executives to determine what steps companies were taking to prepare for the looming May 2020 deadline. We heard:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”

  • “Our challenge is showing management what the cost is per product from a compliance standpoint”

  • “Imagine tracking down paper records for products from the 60s and 70s!”

  • “We will probably have to do a complete revamp of technical files to do resubmission”

  • “Our organization is behind on the IT curve.  It will likely take three to four years to implement a robust global product data management system like that to support EU MDR”

  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

The last point made was a key step in complying with EU MDR and beyond.  With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.
MedTech Europe has issued a position paper asking the EU for a "stop the clock mechanism, that freezes the remaining transition time for both EU MDR and IVDR until full readiness of the system has been achieved."  However, Med-Tech companies must begin to take a long view on EU MDR now and begin their digital transformation journey to support EU MDR and beyond.  During this webinar, I’ll also review our Infographic that offers a road map to sustainable, positive disruption, including some road hazards and areas of interest that we’ve identified along the way.

Please register and join us on September 19th at 9am for a live webinar.
 

Register Now
 

About your presenter:  Sandra K. Rodriguez is a Market Analyst at Axendia, an analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory issues.  Sandra has seventeen years of experience working within the FDA-regulated industries, including sales, marketing and market research projects.  She has presented Axendia’s primary research to FDA Officials and has authored numerous articles and white papers on technology and regulatory trends and their impact on the future of the Life Sciences Industry.  Sandra served six years in the US Army Reserve.

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