The new Regulation sets out an obligation for economic operators to cooperate with the market surveillance authorities and establishes a framework for the control of products entering the Union market.
Medical devices and healthcare
MDR Transitional regime clarified by MDCG
The Medical Devices Coordination Group (MDCG) has published a document on the validity of certificates issued in accordance to the Directive after the new Medical Device Regulation (MDR) becomes applicable.
MHRA Guidance on Assistive Technology: medical device or not?
Products that assist and support individuals with disabilities, restricted mobility or other conditions to perform functions that would be difficult to perform without such products are known as ‘Assistive Technology’.Classifying these products is not an easy task as they might be a medical device or an ‘aid for daily living’. Read more about it.
An interview with Obelis' CEO, Gideon Elkayam
Read on Obelis' CEO, Gideon Elkayam, interview.
MDR in few words
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.
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.
Request to SCHEER for a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma
SCHEER called to release scientific opinion on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) in Europe.
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.