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Registration of persons responsible for placing In-vitro Diagnostic Medical Devices on the market

19 July 2012

The Irish Medicines Board has issued a guide on the registration of persons responsible for placing in vitro diagnostic medical devices on the market.

The purpose of this guide is to outline the requirements in relation to registration of in vitro diagnostic medical devices (IVDs) as required by the Medical Devices Directive 98/79/EEC and Statutory Instrument (S.I.) No. 304 of 2001, European Communities (In vitro Diagnostic Medical Devices) Regulations, as well as to provide guidance on how to complete both the manual and online application forms for registration of these devices.

Guide to registration of persons responsible for placing in vitro diagnostic medical devices on the market

The Irish Medicines Board has revised its application form for the registration of persons responsible for placing in-vitro diagnostic medical devices on the market. This revision includes updated instructions for applicants on the submission of applications to the IMB.

Applications for registration should now be sent to the Clinical Assessment Section, Human Products Authorisation and Registration Department.

Full details are available in the application form below.

Registration of persons responsible for placing In-vitro Diagnostic Medical Devices on the market in accordance with Directive 98/79/EC and S.I. No. 304 of 2001





Date Printed: 19 April 2014

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