There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!
Medical devices and healthcare
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!
Spanish Authority Issues New Guidelines for Personal Care
The Spanish competent authority has updated its instructions for requesting authorisation for commercialising personal care products. Visit our page for more details!
EU IVDR now applies in Europe:What should IVD manufacturers do to comply?
If you are unsure of how you should now proceed in order to import new devices or maintain the previous ones in the European territory, this webinar is what you were looking for! Register now!
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!