13485cert

Revision of EU Medical Device Regulations – Released Yesterday

In CE Mark, CE Medical, Medical CE on September 27, 2012 at 8:34 pm

For those of you that have Google alerts, subscribe to a Notified Body email notification service (and anyone else that is addicted to European Regulations), you are already aware of the new revisions that will eventually replace 93/42/EEC as modified by 2007/47/EC (also fondly referred to as the M5 MDD).

The link for the new revision is already posted on my helpful links section of my website (RA Review). The helpful links was recently re-organized by country. The link is #1 in the European section.

I will be posting commentary on the RA Review site over the next week related to the proposed revisions.

Sorry I’m a day late folks, but it’s not recommended to work on your blog while you’re on vacation. It’s especially dangerous to do so on your wife’s birthday. So everyone, please wish my beautiful wife a Happy Birthday! (September 26th). My 4 year-old daughter Gracie picked the song this week.

Picture from Vacation in Maine

Lisa, Ivy and Andre the Seal

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