Regulatory & Safety Experts for Global Medical Device Approvals
Just found out that the HTML listing of the Harmonized Standards listings are not available anymore. Not that they have been up to date of late anyway but still I refer to them a lot. So, when you search for
This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News
EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.
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
Recently the FDA (United States) has released its latest List of Recognized Consensus Standards & the EU (European Union) has released updated lists of Harmonized Standards for the MDD (Medical Device Directive), the AIMDD (Active Implantable Medical Device Directive), and