The Eu Commission has requested the opinion of the SCCS regarding the safety of several cosmetic ingredients. Find out which ones in this article!
News
New restrictions for Salicylic acid
The European Commission has issued a Corrigendum to its Cosmetic Regulation concerning Salicylic acid. Find out all the details in this article.
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!
MDCG issued Guidance on clinical data of legacy devices (01/03)
The MDCG has issued a Guide for manufacturers and Notified Bodies on Clinical Evidence. Learn all the clarifications on legacy devices in this article.
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How is the Belgian Federal Agency for Medicines and Health Products playing its part to combat COVID-19?
While Governments are decreasing protective measures, it's key to avoid shortage of Covid-19 related products. Find out the latest news on their regulation.
Guidance on Regulatory Requirements for Ventilators and Related Accessories
The Medical Device Coordination Group issued a guidance on how to place ventilators on the EU market during the Covid-19 pandemic. Find out all the details.
Coronavirus: special measures and ban on rapid self-tests in Belgium
Obelis can still assist you in quickly submitting all the other IVDs that are critical for addressing the COVID-19 outbreak!
SCCS Final opinion issued for Aluminum
Learn more about aluminum-containing cosmetic products.