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Erik Vollebregt
It’s not breaking news anymore, but important anyway as this dossier is moving: the EU Parliament approved going forward with the singlish EU patent (singlish because not all EU member states are…
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Erik Vollebregt
Medicaldeviceslegal is proud to report its first sent in medical devices judgment, kindly sent in by James Lawford Davies from the UK life sciences law firm Lawford Davies Denoon. Many thanks James,…
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Erik Vollebregt
ISO 14155, who in medical devices is not familiar with that standard with respect to clinical investigation of medical devices for human subjects? Not that long after the EU had harmonised the…
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Erik Vollebregt
There are at least two IP developments going on in the EU presently that are of great importance to the medical devices industry. First, there are the developments toward a single EU…
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Erik Vollebregt
Earlier this month the EU published a new notice of standards harmonised under the three medical devices directives. Although this in itself is news, I would like to put the spotlight on…
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Erik Vollebregt
I just returned from an interesting conference in Munich about software design for medical devices. I had the privilege to present on legal issues and some regulatory issues related to software and…
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Erik Vollebregt
This post will be more opinionated than usual. Maybe I am overlooking things; if so, readers are welcome to set me straight. I attended a small conference today in the Netherlands about…
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Erik Vollebregt
It is a typical scenario: an M&A project is underway, gains momentum and before you know it the pressure is on. The deal must close in time! And then some regulatory points…
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Erik Vollebregt
With the revision of the EU medical devices directive that entered into force last year stricter requirements on usability engineering have entered into force. The very first essential requirement under that directive…