Ireland:
Knowledge Bites, Part 3: How Does The New Scrutiny Procedure Look?
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The new Medical Device Regulations, whose final drafts were
published by the Council of the European Union last week, will
result in an additional layer of review of technical documentation
for certain manufacturers of medical devices. If you manufacture
implantable class III devices (e.g. pacemakers) or class IIb active
devices intended to administer and/or remove a medicinal product
(e.g. drug delivery systems), you will need to be prepared for two
additional layers of review of your technical documentation.
Read the full briefing here.
This article contains a general summary of developments and
is not a complete or definitive statement of the law. Specific
legal advice should be obtained where appropriate.
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