Guide to the In-vitro Diagnostic Medical Devices Legislation
18 June 2012
The purpose of this document is to provide guidance on the regulatory control of in- vitro diagnostic medical devices on the Irish market. It sets out, inter alia, the key elements of Directive 98/79/EEC on in-vitro diagnostic medical devices and the related Irish Regulation S.I. No. 304 of 2001, European Communities (In-vitro Diagnostic Medical Devices) Regulations, 2001 hereafter referred to as the 'Directive' or the 'Regulation'. In using this guide, reference should be made to IMB Guidance Note 6: Glossary of Terms for Medical Devices, for clarification on terminology.
Guide to the In-vitro Diagnostic Medical Devices Legislation
This guide has been updated. See changes tracked below:
Guide to the In-Vitro Diagnostic Medical Devices Legislation-changes tracked