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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


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