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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.
Joint effort for more knowledge on endocrine disruptors
National authorities from EU countries have developed a database about endocrine disruptors in the EU. Read all the details 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.
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!
The upload of software into radio equipment – Commission’s Clarifications
All radio equipment, including its embedded software, must comply with the Radio Equipment Directive 2014/53/EU (RED). Find out all the details here!
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!
MDR Delay: which provisions have been changed?
1-year delay will provide you with additional 12 months to finalize your compliance with the MDR, which is a complex and lengthy process!
Covid-19 Q&A Guidance Document released by the EU Commission
The European Commission published on April 3rd a Q&A document on medical, implantable active and in vitro diagnostic medical devices to address the emergency situation the medical devices industry is undergoing on a global scale.
MedTech Europe and European Commission approach on EU ArtificiaI Intelligence and Data strategy
Medical device manufacturers are using these technologies to innovate their products to better assist healthcare providers and improve patient care.