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.
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.
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.
Aseptic presentation has been a focus point in the industry for many years, but it will become even more important with the new MDR.
There are two parts in the regulation that are dedicated to validation, which will lead to an increase in demand for validation documentation.
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: