As of August 2020, Lilial (or BMHCA) has been classified as a CMR substance under the EU Classification, Labelling and Packaging regulation.
News
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 BREAKFASTS
Obelis Academy, in collaboration with Norway Health Tech, present a series of Regulatory Breakfasts.
Along these courses, the experts will be addressing the most important topics to be prepared to meet the MDR deadline, with the possibility to book one-on-one meetings with the industry leaders to discuss your specific questions.
Webinar: MDR timeline
Due the 1-year delay will provide you with additional time to finalize your compliance with the MDR, but this is a complex and lengthy process!
As a matter of fact, we are only 9 months away from the date of application, while the full update to the MDR will take up to 18 months.
Let our experts guide you through the steps you need to follow to meet all the requirements in our webinar.
Simplification of conformity procedures for CoViD-19 Pandemic-relevant products in Portugal
In response to the Covid-19 pandemic, the Portuguese government published legislation to increase the availability of Coronavirus-related products. Find out more here!
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!