ISO 13485, “Medical devices — Quality management systems — Requirements for regulatory purposes,” was approved in final draft format at the end of the year. FYI: Voting on the final draft closed on 12/29/2015 and the publication has been accepted. This means that we’ll see the release (at last) of the new 3rd Edition of this essential medical device standard sometime during the first quarter. For those of you in this industry, it’s just one of a series of major changes coming to your regulatory and compliance environment. Get ready for a wild year!
What’s been going on with the ISO 13485? Let’s say, what hasn’t been going on with it! The whole issue of risk management for medical devices has been under intense scrutiny for the last several years. This is the result of the faulty breast implant devices provided by a French manufacturer (the PIP scandal.) Now we’ll be seeing the results of the discussions and negotiations.
First, the ISO 13485 hasn’t been updated since 2003, which is a fairly long time considering the changes in our approaches to risk management. Secondly, not only will the standard be updated, but the EU regulations for both medical devices and in vitro medical devices will also be revised this year. Click here for the official executive summary of the regulatory impact assessment of the proposed EU Directives’ changes.
Of course, those of you in the industry will be grateful for better guidance with regards to the issue. These last few years of poorly defined expectations with regards to appropriate risk management parameters has been difficult for many of our Document Center customers.
Your main changes to the ISO 13485 should be in the areas of regulation, risk management, validation, verification, and design transfer, your outsourcing practices, and post-market feedback. There has also been a push to have all quality standards meet the same format as the ISO 9001. So you will see extensive documentation of the relationship between the two documents.
You will have three years to make the transition to the new ISO 13485 2016. If you’re anxious to take an “early bird” look at the changes you are always welcome to purchase the final draft. Just be aware that you will have to repurchase the new edition once it is released.
Concerned that the new edition will come out and you won’t be informed? Contact our Document Center staff to get put on our notification list for this standard. We’ll send you an email as soon as the new 3rd Edition is published. Have additional questions or want to get a copy of the draft? You can get in touch with us by phone (650-591-7600) or by email (info@document-center.com). We’ve been working with ISO standards under contract since the early 1990’s. You can make us your Standards Experts with confidence.
