In this article we give you an overview about the MDR requirements that a legacy device must met to be considered compliant.
Medical devices and healthcare auto
Use of Octylphenol ethoxylate (Triton-X-100) banned in medical devices and IVDs
The Commission Regulation (EU) 2020/2160 has restricted the use of Octylphenol ethoxylate in Medical Devices and In-Vitro Diagnostic Medical Devices from December 22, 2023, onwards. Want more details? Visit our page!
Legacy Devices and Certificates: Updates from BSI
The BSI announced in June of 2021 updates concerning certificates issued for medical devices. Do you want to know how these changes will affect manufacturers and their industries? Visit Our Website.
French CA issues procedure deal with risks of rupture of essential medical devices and IVDs.
The French CA together with the ANSM has published a management procedure to support the market operators and prevent a shortage of medical devices and in- vitro diagnostic devices.
WEBINAR: EU- SWISS MRA LATEST
Medical device trade is affected by MDR and lack of MRA update. Find out all the details!
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.