PackTalk is a blog for the Healthcare Packaging Industry

MDR Starts on May 26; Read This to Get Ready


Published on May 25, 2021

MDR has been a part of our vocabulary since 2017. It was postponed last year, but the time is finally here. On May 26, 2021, the European Union Medical Device Regulation (or, EU MDR) will finally be implemented. Since the announcement of this new regulation, all notified bodies and medical device manufacturers across Europe have been actively preparing. By now, stakeholders are aware of what must be done. But with that said, it is an extensive regulation, so we also know companies who are wondering if they’ve interpreted MDR correctly, and more importantly, if they comply or not.

Last year, we hosted a webinar called MDR: Top Things you Need to Know as a Packaging Engineer. The webinar presented a practical overview of MDR and how it applied to the packaging process. With MDR roll-out upon us, we’re summarizing the 5 key changes discussed in the webinar.

  1. Notified bodies have more accountability in the MDR, which will be clear as they begin to scrutinize medical device manufacturers more heavily. This might lead to MDMs becoming more conservative as notified bodies dive deeper in auditing and reviews.

  2. There will be a stronger emphasis on analyzing hospital handling and storage to better understand the packaging dynamics in these locations. Packaging in the last mile it it’s journey will get more attention, too. This might lead to up-front changes in packaging design.

  3. Aseptic presentation has been a focus point in the industry for many years, but it will become even more important with the new MDR.

  4. There are two parts in the regulation that are dedicated to validation, which will lead to an increase in demand for validation documentation.

  5. Finally, the new MDR will include updated labeling requirements; or example, showing the difference between a sterile barrier and a protective barrier. The Sterile Barrier Association (SBA) has come up with documentation on these symbols with ideas on how to apply the symbols with different kind of packaging. On their website, you can find documents with more information, including the Guidance Document EN ISO 15223-1 new symbols for SBS (Ref: 201908-1 v5).

These are the high-level changes that are important for packaging. However, if ISO 11607 is your standard guideline, you will already be ahead of the game, with ways to reduce patient risk.

Just remember, we’re all in this together as we work to interpret and implement the new MDR. Want more information about MDR and packaging, check out the following resources:


Comments (0)

Related Articles

How One Patient’s Experience Became a Profession

September 24, 2023

It was 12 years ago this past summer, but I can remember it all like it was yesterday. I was getting headaches that were a stinging pain in the back of my head. They would come and go, and often with a quick movement the pain would change. I was also...

Learn More

The History of DuPont™ Tyvek®

September 24, 2023

As a material that took 15 years to fully develop and another 15 years to hit the mainstream market, the story of DuPont™ Tyvek® is one of humble beginnings. Fast forward to today, Tyvek® is recognized as a global leader in sterile packaging and shows no...

Learn More

How to Measure and Select the Best Medical Packaging Materials

September 24, 2023

When facing customer inquiries about packaging materials, some of the most common questions we encounter are: What is the thickness of the film material; how do you convert mil and ga; and, how thick is X ga material? When selecting packaging materials,...

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.