In 2008, the European Parliament and the Council jointly adopted the Decision No. 768/2008/EC aiming to set a common framework for a new Industrial Policy. Read more
Medical devices and healthcare auto
IVDR: What are EU Reference Laboratories (EURLs)?
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!
IVDR: Clinical Evidence Requirements for Manufacturers
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!
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.
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.
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!
A reinforced role for the European Medicines Agency (EMA)
The EU regulators agreed to introduce a new set of tools to improve the EU health security coordination before and during crises by reinforcing the management of disruptions due to the scarcity of medicinal products. Want to know more? Visit our page!
Cobalt in medical devices: French CA publishes a Q&A document
The French competent authority (ANSM) has published information for medical devices containing COBALT. The ANSM informs manufacturers that as of October 1, 2021, cobalt will need to be clasified differently. Want to know more? Visit our page!