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,…


EU privacy requirements for (healthcare) apps – the Article 29 Working Party weighs in

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 distributing healthcare…


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…


EU Court judgment may add 6.5% customs tariff burden for parts/accessories of medical devices

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 Combined…

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