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MedTech Europe and European Commission approach on EU ArtificiaI Intelligence and Data strategy
Medical device manufacturers are using these technologies to innovate their products to better assist healthcare providers and improve patient care.
Do you want to place your 3D printed product on the EU internal market to be used in a medical context and fight against COVID-19?
Is there any applicable EU legal framework in the case of 3D printing?
COVID-19: Free European standards and easier MD & IVD registration
Europe adopts new measures to respond to COVID-19 outbreak, including measures to speed up MD & IVD device EU market introduction and free info on EU standards.
Not all CBD extracts should automatically go through a novel food application
Cannabidiol (CBD) has been capturing more and more the attention of manufacturers and consumers in many different consumer products, particularly in food supplements in view of its multiple and alleged beneficial properties for human health. CBD is a non-psychoactive compound and one of the many cannabinoids contained in Cannabis.
EUDAMED POSTPONED, CONSEQUENCES FOR COMPLIANCE?
So which actions do Manufacturers have to take to be MDR COMPLIANT for the EU market?
Read more about it here.
EDPS Opinion on clinical research and data protection
Read more about the opinion of the European Data Protection Supervisor holds for the implications of GDPR on clinical research conducted within the EU.
The European Commission has published a FAQ document on UDI
Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain. Read more about it here.
Danish competent authority bans phthalates and boron releasing toys
As squishy and slime toys are becoming increasingly popular among children, many EU member states have been strengthening inspections for harmful chemicals in their composition.
Type-approval for vehicles: Revised General Safety Regulation enters into force
As of July 2022, the new rules require all vehicle models introduced on the European market to be equipped with advanced safety features.