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!
Medical devices and healthcare
HPRA 2020 Annual Report
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!
«A new industrial strategy for Europe» an update
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.
Tattoo inks and permanent make-up pigments: new restrictions
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.
Obelis Group winner for the Trend Gazelles Award 2022!
We are proud to announce that Obelis has been nominated for the Trends Gazelles 2022 award in the category of medium enterprises! Want to know more? Visit our page!
The European Commission’s quest against “greenwashing”
The EU has carried out a yearly “sweep” exercise on market vigilance to protect consumers against untruthful green claims. This is part of the European Commission’s New Consumer Agenda to support both EU’s digital and green transition.
Circular economy, AI and product liability: The European Commission launches a new public consultation
The European Commission has launched a public consultation on the rules on compensation for damage caused by defective products. Do you want to know more? Visit our page!
MedTech Europe: The value of digital health in the European Union.
Are you part of the European Medical devices industry? Are you currently developing new technologies to improve the European health systems?
Check out this interesting summary regarding MedTech’s latest position paper on digital health apps.
Transplants & medical devices: the Spanish Authority presents RENACER
According to the Spanish Association of Cardiology, there has been an increasing number of urgent transplants and medical devices to support said transplants in the last years. Want to know more? Visit our page!
Congress on Regulations and Compliance for Cosmetics (CRCC)
For the 6th year consecutively the European cosmetics Responsible Person Association (ERPA) is organizing the annual Congress on Regulations and Compliance for Cosmetics. Want to know more? Visit our page!