The IVDR Might Require 264 Notified Bodies

Dr. Oliver Eidel
Updated June 12, 2024
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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.

Notified Bodies Realize That IVDR Could Be a Problem
In November last year, Notified Bodies released a position paper in which they argue that the IVDR could pose some problems (surprise).
Some interesting numbers here: Under the IVDD, only 7% of IVDs required a Notified Body assessment while that number will climb to 84% (!) under the IVDR. That’s a 12-fold increase – crazy!At the time of writing, only 4 Notified Bodies were designated under the IVDR, with one dropping out on Dec 31st, 2021, due to Brexit. (Now there are 6; under the IVDD, there were 22.)They proposed postponing the IVDR or extending the transition (grace) period. They partially blame it on Covid. So, doing some simple math here.. if we have a 12-fold increase in Notified Body Assessments, wouldn’t we need a 12-fold increase in Notified Bodies? That would be 264 Notified Bodies then. Instead we have.. six. Thinking further, now, those six Notified Bodies have to increase their efficiency by a factor of 44 to cover the workload.

European Commission Extends IVDR Grace Period
The European Commission amended the IVDR (press release) to extend the grace period. It’s somewhat hard to simplify, but the TLDR is that you can, at minimum, make your device available until May 26th, 2025 (at least), if you declare your conformity until May 26, 2022. This transition period might be even longer, based on your risk class.
I think it’s somewhat ironic that “patient safety” is mentioned multiple times in the amendment in the context of “the IVDR will endanger patient safety because IVDs will disappear from the market”. Wasn’t patient safety the goal of the MDR and IVDR in the first place? But now we have to slow down their implementation for patient safety. Okay.
We’re heading towards another “let’s place all sorts of devices on the market until May” scenario this May. This time not for MDD, but for the IVDD 🙂
So if you’re an IVD startup, now’s the time to get your product done.

Website and Template Updates

Updated Template: Risk Management Report, Software Development and Maintenance Plan
A very small update to these two templates to include placeholders of mentioning your 62304 software safety class. It’s enough if you mention your class in one of those two places – and can point that out to an auditor when they’re looking for it. 

On a different note: Do you still have lots of questions about the EU MDR and would you like to talk to a human? No worries! We offer our Regulatory Strategy Workshop to companies like yours, in which we sit down with you for two hours, answer all your questions and come up with a plan with which you’ll bring your product to market. For only 400€!

Or, if you don’t like talking to humans, check out our Wizard instead. It’s a self-guided video course which helps you create your documentation all by yourself. No prior knowledge required.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to automate your compliance, look no further. We’ve built Formwork, and it even has a free version!

And finally, if all of this doesn’t sound helpful and your situation seems hopeless, check out our consulting 🙂

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