Arthur Cox is one of Ireland’s leading law firms. For almost 100 years, we have been at the forefront of developments in the legal profession in Ireland. Our practice encompasses all aspects of corporate and business law. The firm has offices in Dublin, Belfast, London, New York and Silicon Valley.
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...
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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.
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.
Knowledge Bites, Part 3: How Does The New Scrutiny Procedure Look?
IrelandFood, Drugs, Healthcare, Life Sciences
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Arthur Cox is one of Ireland’s leading law firms. For almost 100 years, we have been at the forefront of developments in the legal profession in Ireland. Our practice encompasses all aspects of corporate and business law. The firm has offices in Dublin, Belfast, London, New York and Silicon Valley.
