The UK tax authority HMRC sent to businesses in GB a letter on how to prepare for new processes for moving goods between UK and EU from 01/01/21. Read more here!
Medical devices and healthcare auto
Medical device procurement in Vietnam: How many Free Sales Certificates do you need?
Learn more about the new procedures for medical device procurement in Vietnamese public health facilities and free sales certificate requirements and limits.
Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU
The MHRA has released its latest guidelines for medical device requirements for products in Great Britain, Northern Ireland, and Europe from January 1st 2021.
MedTech Europe raises industry concerns over the successful transition to the new IVDR
Trade association MedTech Europe has raised concerns over halted progress in transitioning to EU in-vitro diagnostic medical device regulation 2017/746.
Covid-19 IVD Webinar: How to register test kits in Europe?
Due to the outbreak of the Covid-19 in Europe, the European Union is registering increasing shortages of test kits and IVD-related devices. IVD manufacturers need to move fast to secure the supply of such devices on the European market.
Join our FREE Webinar to find out how to register IVDs in Europe.
Simplification of conformity procedures for CoViD-19 Pandemic-relevant products in Portugal
In response to the Covid-19 pandemic, the Portuguese government published legislation to increase the availability of Coronavirus-related products. Find out more here!
Regulatory requirements for medical face masks – European Commission Guidance
The European Commission has issued market and compliance guidance on regulatory requirements for manufacturers of medical face masks.
Faster access of IVDs on the French market
Due to the COVID-19 health emergency, France issued a Decree to ensure detection tests' availability. Find out more!
UK’s Guidance on 3D printing of medical devices or component parts during the pandemic
Different requirements apply for 3D-printed products, depending on their classification as MDDs or PPEs. Find out UK's Guidance in this article!
Personal protective Equipment and Medical Devices in the Covid-19 context –how can they be lawfully placed on the EU market?
The Covid-19 pandemic created a huge demand for PPEs and MDs, but how can you place them on the EU market lawfully? Read the detailed explanation here.