Free movement of medical devices
Medical devices only bearing the European CE conformity marking shall be admitted for placing on the market or putting into service, indicating assessment performed on respective devices for conformity with one of the following European directives/decisions of the Government of Romania as applicable to the type of device:
Directive 93/42/EEC on medical devices (MDD)/Government Decision no. 54/2009
90/385/EEC on Active Implantable Medical Devices (AIMD)/Government Decision no.55/2009
Directive 98/79 EC on in vitro diagnostic medical devices (IVD)/Government Decision no. 798/2003
The CE marking must be affixed visibly, legibly and indelibly on the device or its sterile packaging, where possible, as well as on manufacturer’s instructions for use. The marketed packaging of the device must also bear the CE marking.
Custom-made medical devices and those for clinical investigation are exempt from this rule, i.e. CE marking is not mandatory in their case.
Procedures and procedure packages do not bear additional CE marking.
Considering that users and healthcare providers, in particular, may use medical devices only meeting applicable legal provisions, knowledge of legislation on medical devices is mandatory.
In order to ensure compliance of medical devices with applicable requirements as well as their placing on the market according to the law, healthcare providers must request the manufacturer for compliance documents (the EC declaration of conformity and the conformity assessment certificate, as applicable).
To prevent potential quality/performance-related difficulties in use of medical devices without specialist support, users need to check the CE conformity mark on purchase of the medical devices.