In the context of the Covid-19 emergency, the Minister for Health is given the power to authorise the placing on the market or putting into service of non-CE marked medical devices. Consequently, the European Communities (Medical Devices) Regulations 1994 and the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 are amended.
S.I. No. 145 of 2020. EUROPEAN COMMUNITIES (IN VITRO DIAGNOSTIC MEDICAL DEVICES) (AMENDMENT) REGULATIONS 2020.