PackTalk is a blog for the Healthcare Packaging Industry

Are You Ready For MDR?


Published on October 18, 2019

If you are a medical device manufacturer (MDM) or work in a support industry to the global medical device market, you are probably familiar with the date May 15, 2020. It is then that the three-year transition to the Medical Device Regulations (MDR) governing document (adopted by European Parliament in 2017), comes to a close. Every MDM that markets products in the EU is impacted by the MDR.


The previously governing Medical Device Directive went into effect in 1993. The 2017 MDR presented two significant conditions that did not exist in 1993. Addressing these critical gaps would shape how the industry is governed going forward, specifically 1) the introduction (and subsequent explosion) of technology and software as intrinsic to the use of medical devices, and 2) the demand for transparency, technical information and traceability. These overarching needs and patient safety concerns have ushered in and will continue to impact the approval process for all MDMs serving the EU market.

The transformative nature of the MDR and its fast-approaching deadline comes with many questions. Wherever your organization lies on the spectrum of awareness and implementation of the stringent new requirements, we’ve curated some resources that may help you assess your readiness and plan the next steps.

Oliver Healthcare Packaging will continue to track and report on noteworthy MDR developments.

 


Comments (0)

Related Articles

New Nylon Opens Door for Companies Looking to Upgrade Packaging at a More Afford...

July 3, 2020

To our readers … you know by now that we never push our product through PackTalk. In this blog, we aim to educate & inspire, and ultimately start a discussion. But we’re breaking our own rule for this article.  The healthcare industry is conservative...

Learn More

Analysts Report Positive Signs for Elective Procedure Volume Recovery

July 3, 2020

During the peak of COVID-19, a majority of non-emergency or elective medical procedures were put on hold. The lack of procedures had a significant impact on the medical device industry and it’s still questionable when we’ll see procedure volume return to...

Learn More

Healthcare Agility in the Time of COVID-19

July 3, 2020

The healthcare world has faced a massive shift in recent months to focus on fighting the COVID-19 pandemic. The medical system has suffered unprecedented strain, and there has been global coordination in ways we have never before seen. Hospitals have...

Learn More

Stay Informed

To stay up to date on innovative technology and products, as well as industry trends, subscribe to Oliver’s PackTalk blog below.