Asphalion MedTech | UK and US services

We can act as your UK responsible person and as you US agent

We can act as your UK responsible person and as you US agent
May 15, 2023

At Asphalion we can facilitate your product’s MedTech journey in the UK and US environments.

Our expertise and high knowledge and understanding of both US and UK regulations can help you establish the best regulatory strategies in these two markets.

Have a look at everything we can help you with!

For further information, send us an email at:

You can also schedule a free 30-minutes meeting with our experts HERE.

Have a look at our MedTech UK & US Solutions

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NEWS | New Insight on the Implementation of MDR Article 17

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

The European Union’s AI Act & its Impact on Medical Devices

The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

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