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EU Court judgment may add 6.5% customs tariff burden for parts/accessories of...
And now for something completely different: customs tariffs. Dry stuff, but it makes all the difference for the price of the device. Indeed, ‘parts’ and/or ‘accessories’ under heading 9018 of the...
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Regulating Medical Software and nothing new on the Recast
Today I attended the COCIR workshop Regulating Medical Software in Brussels, a very interesting event that brought a lot of new information to my attention and I had the opportunity to speak to many...
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The new EU MEDDEV on stand-alone software as medical device
Some time ago I already gave you a look under the hood of it and now it is here, the new MEDDEV on stand alone software: an interesting document that provides a lot of much-needed guidance for the...
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E-labelling regulation published, no changes / big disappointment
Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did) there is absolutely no...
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Happy New Year – with all those developments
The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will...
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EU privacy requirements for (healthcare) apps – the Article 29 Working Party...
The European Article 29 Working Party has just released its opinion 02-2013 on apps on smart devices. This detailed opinion provides very useful and detailed guidance for companies developing and...
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IMDRF invites comments on standalone software key definitions
As announced, the IMDRF is on the case for software, which shows how important this subject is becoming in the medical devices field. I notice this everyday in my medical devices practice, as more and...
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