Find all data collected and results from the Italian National Registration for Breast Implants pilot phase. Read it now!
Medical devices regulation (MDR)
Post-Market Surveillance (PMS) and Vigilance: definitions and differences
Vigilance and Post-Market Surveillance definition, differences and their scope. Visit our webpage for all the details!
What are the effects of the implementation of MDR on the EU medical device market?
Discover the effects of the implementation of MDR on the EU medical device market and the most relevant challenges in our new article!
MDR: Notice to Manufacturers for Implementation
Medical devices that have obtained CE Certificate under the MDD 93/42/EEC can circulate in the EU market. Learn the conditions here!
Compliance Success Stories: Meet Samsara Vision!
An interview with Samsara Vision about the different compliance steps and the process to launch their products in the market.
Obligation on icons and symbols to display for manufacturers of medical devices
In January 2022, the Journal of the European Union published harmonised standards for medical and health care products, including symbols that manufacturers must provide for their products. Read all the details!
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!
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!
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.