With the In Vitro Diagnostic Medical Devices Regulation (IVDR), the IVD sector in the European Union is about to experience significant changes. From a new classification system to stricter assessment procedures and market surveillance. Read the full article to discover all the details!
Article 56 (1) of the Regulation on in vitro diagnostic medical devices states that manufacturers must specify and justify the level of clinical evidence in view of the characteristics of the device and its intended purpose. Read all the details!
The European Commission updated the explanatory guidance document for the Toy Safety Directive (TSD) on 16th of December 2021. One of the most significant changes concerns instructions and safety information on the website, language requirements and second-hand toys. Read the full article for all the details!
The ECHA’s Enforcement Forum has found that most inspected products sold online breached at least one requirement in EU chemicals law. Read the full article to know all the details!
According to Regulation (EU) 2021/1099 dated July 5, 2021, Deoxyarbutin has been added to the list of substances prohibited for use in cosmetics. At the same time, some restrictions have been imposed on the use of Dihydroxyacetone. Read our article to know more details!
In this webinar, we will go through the requirements to comply with the European Cosmetics…
Each year, Health Products Regulatory Authority (HPRA) publishes the annual report outlining its activities in the area of public and animals’ health. The Irish agency’s new report was published on November 20, 2021, and summarises last year’s programs development to regulate health products and the safety of cosmetics. Read the full article to know more!
Find out more information on the new EU requirements on labels for cosmetics with a special focus on environmental aspects
The Industrial Forum was created in 2021 to assist the Commission in implementing the 2020 «new industrial strategy for Europe». On the 2nd of December 2021, the Forum’s third meeting took place! Read the full article to discover the latest update about it.
Therefore, tattoo inks and permanent make-up pigments have been recently evaluated for long-term safety by ECHA. As a consequence, the European regulators have introduced new restrictions for tattoo inks and pigments under the REACH Regulation from January 4, 2022.