Trade association MedTech Europe has raised concerns over halted progress in transitioning to EU in-vitro diagnostic medical device regulation 2017/746.
Medical devices and healthcare
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.
Free Sales Certificates needed for medical device registration in Bosnia and Serbia
It is well known that for Medical and In Vitro Diagnostic Devices, the best tool easing the access to non-European markets is the Free Sales Certificate, which allows the manufacturer to prove the compliance of his devices with the EU laws and safety standards. These EU standards are then fully accepted and welcomed as the best possible ones also outside the European Union, typically as an official proof of compliance or generally to clear the Customs.
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.
National MDR implementation – Germany’s establishment of NAKI
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!
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.
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!