In May 2020, the Office for Product Safety & Standards issued a guidance for the placement on the UK of hand cleaning and sanitising products.
The demand for these type of products has risen, as a consequence of the COVID-19 pandemic, and it is common for manufacturers and importers to be confused when it comes to which legislation these products fall under.
The government of the UK has published on its official website some regulatory flexibilities resulting from coronavirus.
MedTech Europe published a statement on the European Strategy for Data. Read about this step forward towards Europe’s digitalized health system here.
To display full information for users of medical devices, the UK set up a new reporting site: the Yellow Card. Find out more about it in this article!
The Belgian FAMHP issued a guidance document listing critical devices for health systems during the Covid-19 pandemic. Find out what is on the list here!
As a response to the current shortages of face masks, Belgium has issued a national guideline on the reutilization of these devices. Find out more about it!
What is the path to EU compliance for IVDs? Find the answers to most common questions in this article and clear all your doubts!
In order to face the lack of reliable Covid-19 test devices, the European Commission published the required performance criteria. Read here all the details!
The MDCG has issued a Guide for manufacturers and Notified Bodies on Clinical Evidence. Learn all the clarifications on legacy devices in this article.
The Medical Device Coordination Group issued a guidance on how to place ventilators on the EU market during the Covid-19 pandemic. Find out all the details.