Conformity assessment
The manufacturer must meet all the relevant essential requirements for a medical product that are set out in Annex I of the Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, no. 84/13). Essential requirements, inter alia, include: biological and chemical safety, clinical data, protection against electric shock and electromagnetic compatibility, labelling and instructions for use, risk management and sterilisation.
A conformity assessment is any action relating to directly or indirectly establishing compliance with the essential requirements set out in the technical regulations that apply to the device in question.
The procedures of assessing conformity can be carried out in several ways, and the selection of procedure depends on the risk class of the medical device according to Articles 17 to 29 and Article 31 of the Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, no. 84/13), and the relevant Annexes to that Ordinance.
All conformity assessment procedures require the involvement of a notified body for conformity assessment except the procedure referred to in Annex VII (Class I), Annex VIII (custom-made medical devices and medical devices intended for clinical investigation), Annex III for in vitro diagnostic medical devices (in vitro - others) and Annex VIII for in vitro diagnostic medical devices (in vitro diagnostic medical devices intended for performance evaluation) which the manufacturer performs alone. A notified body is a body that the central competent authority of state administration has notified to the European Commission for the conduct of conformity assessment procedures and which has received an identification number from the European Commission. The list of notified bodies that act within the EU can be found here.
