It is well known that the Medical Devices 93/42/EEC and the IVD 98/79/EEC Directives are leaving space to National Competent Authorities regarding the application of the Laws, and also the eventual imposition of additional requirements when possible. One of the typical examples is the imposition of a National Registration Process.
Spain, Croatia, Bulgaria
Obelis is proud to inform you that we provide assistance for these three countries as well, in addition to Italy, France, Greece, Portugal and Latvia.
In particular, as your official EAR, it is strongly recommended to let us register your devices, instead of any other third party (e.g. distributors), especially in light of the new MDR and IVDR, that will clearly deny this possibility and leave the Registration duty solely in the hands of the manufacturer and the EAR.
Classes of Devices and Service
Generally, the Registration applies to all devices for which there has been a Notified Body intervention, typically upper Class Medical devices (IIa, IIb, III) and all IVD Classes which do not fall into the ‘’All-others’’ category, but there are specific requirements and case-by-case scenarios.
If you would like to fully assess your list of devices and check for which you need a registration and in which country, please do not hesitate to Contact Us, and our National Registration Specialists will provide you with the best possible feedback.