The introduction of the new Regulations on medical devices in the European Union meant stricter controls and reinforced rules on transparency and clinical evidence. Learn more!
Medical devices and healthcare auto
LIVE Roundtable: IVDR is coming- how to get ready!
Don’t miss this unique opportunity to learn suggested strategies and best practices that lead to successful IVDR transition and outcomes!
Shortage of medical and protective equipment: EU strategies to prevent market disruptions
The elimination of barriers and the introduction of free movement of goods, services, and people across the Member States have granted a more dynamic business environment. To learn about the consequences of these new changes visit our page!
Shaping the future of the EU market. The legislative framework for industrial products under revision
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
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.