Medical device trade is affected by MDR and lack of MRA update. Find out all the details!
Medical devices and healthcare auto
Italian authorities confirm: Air purifiers are not medical devices
The Italian Ministry of Health clarified the proper classification of air purifiers and air decontamination systems, as well as their intended use. Find out all the details here!
New Spanish cosmetic guidance: microbiologically safe cosmetic products
The AEMPS in collaboration with STANPA published a new guide to assist in formulating and manufacturing safe raw materials and cosmetic products. More information can be found here!
COVID self-test in Belgium can be sold freely as of the 1st of July 2021
The Belgian Federal Agency for Medicines and Health Products has decided to sell the Covid self-test free of charge in Belgium. More information can be found here.
Final Opinion from SCHEER on breast Implants and ALCL Connection.
SCHEER published its final conclusion regarding the connection between breast implants' safety and ALCL. Find out all the details here!
The New Machinery Regulation Proposal: Enhanced Safety through a Simpler Framework
The Machinery Directive 2006/42/EC is a key piece of EU legislation that follows the ‘New approach‘ principles. Read about the new proposal to update this legislation.
Webinar: EU Perspective on Medical Devices in 2021
Find out more information on the new requirements by MDR and BREXIT
Webinar: Classification rules under IVDR and Covid-19 derogation lists & database
The upcoming IVDR regulation will be fully applicable as of May 26, 2022. There will be changes in the IVDR landscape, and manufacturers must make sure to be compliant on time, in order to keep selling their devices on the European market.
Webinar: Complying with the MDR
The new medical Device Regulation is fully applicable as of May 26, 2021, therefore you need to know how to manage your Legacy Devices Compliance in the EU.
High-risk medical devices in Europe: new methods of evaluation through CORE-MD project
Discover the new methods of evaluation through CORE-MD project on high-risk medical devices in Europe.