Registration of persons responsible for placing Medical Devices on the market
19 July 2012
The Irish Medicines Board has issued a guide to the registration of persons responsible for placing medical devices on the market.
The purpose of this guide is to outline the requirements in relation to registration of medical devices as required by both the Medical Device Directive 93/42/EEC and the Active Implantable Medical Device Directive 90/385/EEC, as well as to provide guidance on how to complete both the manual and online appilcation forms for registration of these devices.
Guide to the registration of persons responsible for placing medical devices on the market
The Irish Medicines Board has revised its application form for the registration of persons responsible for placing 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 Medical Devices on the market in accordance with Directive 93/42/EEC and S.I. No 252 of 1994