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News
Lilial classified as a CMR substance
As of August 2020, Lilial (or BMHCA) has been classified as a CMR substance under the EU Classification, Labelling and Packaging regulation.
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.
MedTech Europe raises industry concerns over the successful transition to the new IVDR
Trade association MedTech Europe has raised concerns over halted progress in transitioning to EU in-vitro diagnostic medical device regulation 2017/746.
Scientific Committee on Consumer Safety opinion on Titanium dioxite
The Scientific Committee on Consumer Safety have published a consumer safety opinion on TiO2, a common ingredient in cosmetics products on the EU market.
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.
AEMPS Information about market campaign control for sunscreen products
The AEMPS started a market control campaign for sunscreen products in relation to SPF. Read all the details in this article!