European Motor Vehicle Regulation 2018/858 entered full effect in September 2020. Talk to our EU regulatory experts about your vehicle or product's compliance.
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Radio Equipment Directive – Obligations associated with the placing on the market
All the information you need on how to bring a product to market under EU Radio Equipment Directive 2014/53. CE marking, documentation, compliance and more.
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.
European Commission published first GDPR evaluation report
More information on the findings of the EC's first evaluation on the effectiveness of the General Data Protection Regulation.
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.
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)
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.