A brief overview of the best path for ensuring full compliance with MDR 2017/745 and the implications it has for medical device manufacturers in Europe.
News
How to understand Basic UDI-DI and UDI
EU regulatory experts explain the Unique Device Identification (UDI) system and what it means for you under EU Medical Device Regulations 2017/745 and 2017/746.
EU – USA Cooperation in Medical Devices
Europe and US set to work together to reduce barriers and increase trade in medical products. Cooperation could reduce manufacturing costs and improve controls.
Upcoming event: RMD + CRCC 2019 in Brussels
Obelis invites you to its 4th ERPA Annual Congress on Regulations and Compliance for Cosmetics and EAAR Annual MDR Conference on October 28-29, 2019.
European Commission Expert Panels on Medical Devices and In Vitro Diagnostic Devices
The European Commission called for the creation of expert panels to advise and support on new EU medical device and in-vitro device regulations.
MDR Update: Notified Body designations and first MDR CE Certificate
European Commission announce first four notified body designations and first CE certificate awarded under Medical Device Regulation 2017/745/EU.
Scientific Opinion on the use of AVO in cosmetic products
SCCS issues scientific opinion on the use of acetylated vetiver oil in EU cosmetic products. Concludes AVO unlikely to cause contact allergies in humans.
Zinc Pyrithione under review by SCCS
Scientific Committee on Consumer Safety (SCCS) review zinc pyrithione as a safe ingredient in EU cosmetics under regulation 1223/2009. Results due October 2019.
SCCS Final Opinion on the safety of Butylphenyl methylpropional (p-BMHCA)
Scientific Committee on Consumer Safety issue their final opinion on the safety of butylphenyl methylpropional for use in cosmetic products in Europe.
New amendments to the Cosmetics Regulation
European Commission issue statement on updates to Annexes VI, II, III, and V of new EU Cosmetics Regulation 1223/2009 and the substances banned by it.