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

Human Factors & Usability: An Interview with Expert Shannon Hoste

October 22, 2021

The FDA perspective on human factors and usability in health care was first published on July 18, 2000, with the issuance of US FDA draft document, “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.” That non-binding...

Learn More

The Quick Pace of Evolution in Healthcare Packaging for Developing Nations

October 22, 2021

Evolution in the healthcare packaging industry is much quicker in developing nations than it is in more developed countries. Continuous improvement is all about minimizing risk while getting products to market quickly is still a top priority. So, what are the...

Learn More

5 Lessons I Learned from My Experience in Healthcare Packaging

October 22, 2021

“Personal development is your springboard to personal excellence. Ongoing, continuous, non-stop personal development literally assures you that there is no limit to what you can accomplish.” – Brian Tracy

In the past 18 years of my career, I have been blessed...

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.