PackTalk is a blog for the Healthcare Packaging Industry

ISO 11607 & EU MDR: Getting Clarity on Risk Management


Published on April 29, 2020

A year after the publication of ISO 11607-1/2 revisions, seeking further harmony with 2020’s EU MDR, new changes are in the works.

It’s not news that review of ISO standards for medical device development is perpetual.  Not only does this keep the folks at ISO busy, it keeps those of us adhering to the standards on our toes, too. For the last year, there has been plenty of discussion of changes to ISO 11607 Parts 1 and 2.

The final implementation of the EU MDR this year was a key impetus behind the February 2019 ISO 11607-1/2 update. What has evolved since the release of the update, however, is further scrutiny. Specifically, regulators considered the broad direction of ISO 11607-2: 4.2. The new, brief clause simply states that medical device development activities should “consider risk management to medical devices.” The lack of detail and room for interpretation has been called into question. Ultimately, agreeing some definition was needed, the amending team has embarked on a refinement process.

Full Article on ISO 11607-2 Risk Management


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.