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!
Medical devices and healthcare
What is new in the European Standardisation system?
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!
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!
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!