Spanish, Croatian and Bulgarian registration of Medical Devices and IVDs

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.

Davide Turchi

Get in touch

Share This

Copy Link to Clipboard