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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…
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Erik Vollebregt
Just before Christmas the European Court rendered a judgment that is important for medical devices companies that have devices that run software and have a graphic user interface (GUI). The case concerned…
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Erik Vollebregt
Many medical devices companies have invested in making their marketing actvities aimed at healthcare professionals Eucomed Code of Ethical Business Practices compliant. Although the Eucomed code has a lot of authority in…
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Erik Vollebregt
The European Commission has revised its rules for the assessment of co-operation agreements between competitors, so called horizontal co-operation agreements. The most important changes for the medical devices industry are in the…