Germany established NAKI, the National Working Group for the Implementation of the new EU Regulations on MDR IVDR. Read all the details in this article!
Medical devices and healthcare auto
Coronavirus: updated guidelines for verifying the compliance and suitability of surgical face masks
Find out in this article the latest guidelines concerning compliance of surgical and face masks, issued by the Belgian Competent Authority (FAMHP)
Guidance for placing hand sanitizing products on the UK market
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.
MHRA regulatory flexibilities resulting from coronavirus (COVID-19)
The government of the UK has published on its official website some regulatory flexibilities resulting from coronavirus.
Data Strategy in the Medical Field: What's the Next Step?
MedTech Europe published a statement on the European Strategy for Data. Read about this step forward towards Europe’s digitalized health system here.
UK’s new dedicated Yellow Card reporting site
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!
Belgium has identified a list of COVID-19 critical devices, which devices are on the list?
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!
Can single-use surgical masks and FFP2/FFP3 masks be reutilized in the context of the COVID-19 epidemic?
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!
In Vitro Diagnostic Devices: main steps to compliance and frequently asked questions
What is the path to EU compliance for IVDs? Find the answers to most common questions in this article and clear all your doubts!
EU Commission guidelines on Covid-19 tests’ performance
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!