Regulatory Compliance News | EU, UK, US & More

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!

Request for scientific opinions of SCCS: certain ingredients under review

The Eu Commission has requested the opinion of the SCCS regarding the safety of several cosmetic ingredients. Find out which ones in this article!

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!

A professional uses an ultrasound machine

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.

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.