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Erik Vollebregt
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between…
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Carine van den Brink
Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips…
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Karin Verzijden
The seminar addressed current and future EU legal and regulatory developments relevant to cell-based therapies. In particular, the seminar focused on how to choose and support the right regulatory pathway for a…
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Carine van den Brink
The seminar addressed current and future EU legal and regulatory developments relevant to cell-based therapies. In particular, the seminar focused on how to choose and support the right regulatory pathway for a…
,
Erik Vollebregt
Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual…