Regulatory News
Regulatory news and other exciting things happening in the regulatory world. Generally speaking, most updates here are about how your life is about to get more complicated and you’ll be writing even more documentation. But there are some much-appreciated exceptions!
No, Telemedicine Software Is Not Class IIa Under The MDR
How is Telemedicine software classified under the MDR? If you’re in Hamburg, the answer might be class I, class IIa, or not at all, depending on who you ask....
Brace for Impact: The New MDR Transition Periods
Brace for Impact: The New MDR Transition Periods It has been much discussed and we covered it in our newsletter before: now - drum roll - the MDR deadline...
July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
I hope you’re having a great summer! Things have quieted down here in Berlin, besides the usual subtle chaos of manufacturers and auditors trying to find out...
Maybe Harmonized Standards Are Becoming Freely Available Soon
Let’s start off my quoting my 30-year-old self, in the depths of the pandemic of 2020, unemployed and ranting about standards: “You might think that if...
The IVDR Might Require 264 Notified Bodies
Happy New Year! We had some restful holidays and I hope you did, too. Here's our first newsletter of 2022 with some IVDR news and minor template updates....
ISO 13485 Amendment, Templates, User Manuals
Quite a few regulatory things have happened recently! Before we wrap up the year, let's take a quick look. We'll be off starting next week, so happy holidays...
MDR Classification Chaos and User Manuals
Hey you, we've published some new articles about regulatory stuff and the things we do. The first one is about the not-so-helpful new MDCG 2021-24 regarding...
OpenRegulatory Newsletter #1: Conference
First off, why the hell are you getting this email? Simple: You signed up for our newsletter at openregulatory.com and probably forgot about that. That's my...