por Isabel | Abr 14, 2021 | Uncategorized
If you manufacture, distribute or have had an idea for a product or software in the health field, you should know whether it is a medical device. Given the large number of definitions in circulation, it is worth considering the one offered by the Spanish Agency for...
por Isabel | Feb 17, 2021 | Uncategorized
The new regulation on medical devices is almost upon us. In May 2021 the Medical Device Regulation 745/2017 will enter into force. In order to facilitate the implementation process for medical device manufacturers, the European Commission has produced various...
por Isabel | Feb 10, 2021 | Uncategorized
Dicopt is the virtual reality technology for the treatment of lazy eye in children devised by our client V-Vision. The good news is that it has just been recognised as a registered medical device by the AEMPS. V-Vision, our client since March 2020, is the Spanish...
por Isabel | Ene 27, 2021 | Uncategorized
The Medical Devices and In Vitro Diagnostic Regulations (MDR 745/IVDR 746) have established a new role for manufacturers and their authorised representatives, if the manufacturer is not located in the EU. This is the “person responsible for regulatory...
por Isabel | Ene 20, 2021 | Uncategorized
In this blog we have discussed how to obtain a CE marking for your medical device in Europe. But what is the system like in the United States? This must be done through the Food and Drug Administration (FDA). This is the consumer protection agency of the Federal...
por Isabel | Ene 13, 2021 | Uncategorized
The Brexit transition period ended on 31 December 2020. This concluded the UK’s representation in EU institutions, agencies, bodies, organs and bodies. The new trade and cooperation agreement with the UK is effective from 1 January 2021. We summarise the most...
