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Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ

EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.

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Where is EU headed with Proposed Medical Device Regulations by ENVI?

The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of devices.  Note, this issue is not set in stone and you should read some of the [...]

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Great Resource – Current/Draft IEC 60601/80601 Series of Stds & Test Rprts Now Available

We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.  

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MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System Updated to Rev 8

This blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013.  The revised guidance is applicable as of July 2013.   The revision contains clarifications rather than significant changes.

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EU MDD, AIMDD, IVDD Harmonized Standards (EN980 & EN ISO 15223-1) Ooopppss!

The EN 980 Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, ’13 release and EN ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General [...]