Cognition® Corporation Releases White Paper Upcoming EU Regulation of Medical Devices

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New White Paper Speaks to Preparing for the Implementation of the EU’s new Medical Device Regulation

Cognition Corporation White Paper: Managing the Transition to EU MDR Regulations
"There's a lot happening with the EU MDR... By leveraging some of the methods we suggest in this new white paper, we believe that will go a long way in helping these manufacturers streamline the transition."

Cognition® Corporation, a software company specializing in medical device compliance and commercialization, has just released a new white paper on the upcoming implementation of the European Union’s Medical Device Regulation (EU MDR).

The MDR is a new regulatory framework for the oversight of medical devices submitted to and cleared for market in European Union Member States. Intended to replace the previous Medical Device Directive established in 1993, this new regulation is set to see full implementation in May 2020.

“The transition to this new system of regulatory compliance is going to be a challenge for medical device manufacturers,” says David Cronin, CEO of Cognition Corporation. “We’re releasing this paper in the hopes of helping some organizations understand and prepare for the changes ahead in the European market.”

The new white paper takes a high-level approach to the EU MDR, laying out the basics before diving into certain preparatory methods manufacturers of medical devices can undertake. Strategies such as planning ahead, keeping an eye on device classification, and ensuring robust risk management are reviewed.

“There’s a lot happening with the EU MDR,” says Mr. Cronin, “and even though it was published back in 2017, there are still organizations who have yet to come into compliance before the official implementation date. By leveraging some of the methods we suggest in this new white paper, we believe that will go a long way in helping these manufacturers streamline the transition.”

Mr. Cronin adds that the paper will offer suggestions for meeting the MDR’s robust postmarket surveillance requirements as well. “Just like the FDA, the EU is getting more concerned with the total product lifecycle,” says Mr. Cronin. “By highlighting this in our paper, we hope to bring more awareness, and hopefully give folks a chance to better understand what the EU MDR is all about.”

The white paper is available for download here.

Cognition® Corporation, based in Lexington, Massachusetts, has offered solutions for product development compliance for more than fifteen years. Cognition offers the Cognition Cockpit® Platform, along with engineering and validation support, and industry expertise. Thousands of users worldwide use Cognition solutions to manage their product development process and meet regulatory, performance, and-time to-market goals. For more information, visit http://www.cognition.us or call (781) 271-9300.

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Alex Critch
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