An interview with Sarah You about her experience in following one of our expert’s professional trainings on EU Regulations and the insights she gained from it.
Medical devices and healthcare
There was a general agreement between the Council of the EU representing the EU Member States and the European Commission to extend the transitional period (legacy period) to the Medical Devices Regulation (MDR). Read all the details in our article!
To modernise the European Standardisation System, the European Commission proposed to amend the Standardisation Regulation as part of its European Standardisation Strategy of February 2, 2022. Read all the details in our article!
There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!
Vigilance and Post-Market Surveillance definition, differences and their scope. Visit our webpage for all the details!
The European Commission issued a proposal to restrict microplastics. The regulation will have an impact on products containing those substances. Read more!
Discover the effects of the implementation of MDR on the EU medical device market and the most relevant challenges in our new article!
Medical devices that have obtained CE Certificate under the MDD 93/42/EEC can circulate in the EU market. Learn the conditions here!
Join our latest Webinar about the EU IVDR vs. the Swiss IVDO.
Watch the recording to discover all the details from our expert!
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!