Learn more about the new ISO standards set for evaluating the biocompatibility of medical devices on the European market.
News
Regulation (EU) 2016/1628 – Pollutant limits in non-road machinery
Find out more about the products and vehicles affected by EU Regulation 2016/1628/EU relating to gaseous and particulate pollutant emission limits in Europe
New intended bans on the use of preservatives in cosmetics have been notified to the WTO
Read more on the new bans on the use of preservatives in cosmetic products.
The three forbidden Tagetes
The use of Tagetes erecta flower extract, Tagetes erecta flower oil and of Tagetes minuta, patula extracts and flower oils in cosmetic products is now prohibited. Read more about it here.
PVCs in medical devices
PVC materials are nowadays widely used in many applications like containers or tubing, due to its easy and cheap production, flexibility, versatility with different shapes and designs, chemical withstanding and hygienic properties. Read more about it.
The Medical Device Coordination Group gives guidance on the UDI database for the particular cases of Systems and Procedure Packs and Medical Device Software.
The Medical Device Coordination Group for the EU has issued guidance on using the UDI database for medical device software and systems and procedure packs.
The safety of nano Styrene/Acrylates copolymer and nano Sodium Styrene/Acrylates copolymer still raises question marks
“Nanomaterial” means an insoluble or biopersistent and intentionally manufactured material on a scale from 1 to 100 nm. Read on the necessary notification time.
The updated technical document on cosmetic claims limits the use of “free of” claims
New updates to technical documentation on cosmetic product claims limits the use of 'free of' claims and statements on products placed on the EU market.
Spanish Database for Medical Devices and IVD registration changed!
Spain has released a National Registration Process in addition to adopting new EU medical device and IVD regulations and directives.
MBBT (nano) is now approved for use in cosmetic products
The European Commission has amended Annex VI of the Cosmetics Regulation in June this year in what concerns the entry of the nano-sized UV filter called Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (MBBT).