Germany established NAKI, the National Working Group for the Implementation of the new EU Regulations on MDR IVDR. Read all the details in this article!
Consumer goods
The upload of software into radio equipment – Commission’s Clarifications
All radio equipment, including its embedded software, must comply with the Radio Equipment Directive 2014/53/EU (RED). Find out all the details here!
In Vitro Diagnostic Devices: main steps to compliance and frequently asked questions
What is the path to EU compliance for IVDs? Find the answers to most common questions in this article and clear all your doubts!
MDR Delay: which provisions have been changed?
1-year delay will provide you with additional 12 months to finalize your compliance with the MDR, which is a complex and lengthy process!
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.
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.
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.
Second Corrigendum to the MDR: A Christmas gift for manufacturers
The second corrigendum to Regulation (EU) 2017/745 on medical devices has brought a change in the wording of certain part of articles 78(8), 120(3), 120(4), 120(8) and 122; but what does it imply for the concerned economic operators?