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Medical devices and healthcare auto
European Authorised Representative (EAR) for manufacturers based in Turkey
There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!
New Proposal from the EU Commission for a Cyber Resilience Act
European Commission presented a proposal for a Regulation on cybersecurity requirements for products. Read more!
The Italian National Registration for Breast Implants – Results of the pilot phase
Find all data collected and results from the Italian National Registration for Breast Implants pilot phase. Read it now!
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!
EU addresses microplastics issue with regulation proposal
The European Commission issued a proposal to restrict microplastics. The regulation will have an impact on products containing those substances. Read more!
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!
Webinar: IVDR vs IvDO
Join our latest Webinar about the EU IVDR vs. the Swiss IVDO.
Watch the recording to discover all the details from our expert!
HPRA Warns of Dangerous Melanotan 2 in Tanning Products
On June 27, 2022, the Health Products Regulatory Authority (HPRA) published an alert about the serious health risks linked to the substance Melanotan 2. Read all the details!