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 documents on the different aspects covered...
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...
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 compliance". This PRRC has certain obligations and...
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...
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 important points for distributors...
One of the novelties we are offering this month for our customers is assistance in obtaining a certificate of free sale for the export of a medical device. What are they? How are they obtained? we have prepared a post where we explain it to...
Registration for the EUDAMED Single Registration Number (SRN Eudamed) for the 27 countries of the European Union, Iceland, Liechtenstein and Norway is underway as of 1 December. As we told you in our blog, EUDAMED (European database on medical device) is the database of information on...
In these times "we focus our efforts on business sustainability" (Cartronic). Cartronic entered the market with a medical patient monitoring device that quickly made its mark on the healthcare-technology scene. They are now tackling Covid-19 with a focus on "ensuring the well-being and safety of their...
We are currently witnessing a change in the regulation of medical devices. The current Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/ECC) will be replaced by the European Medical Devices Regulation 2017/745 (MDR) in May 2021. As we have already mentioned in other...
Congratulations! Our client 2EyesVision has just announced that it has been awarded ISO 9001:2015 certification. This achievement is the result of the collaborative work of EpisKey Medical Consulting S.L. and 2EyesVision, a laborious process in which Diana Martín, the startup's Quality Manager, has worked tirelessly....
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