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.
Medical devices and healthcare
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.
MDCG released Guidance on the role of the Person Responsible for Regulatory Compliance (PRRC)
Medical Devices Coordination Group have issued guidance on the new role of the EU Responsible Person under EU medical device and in-vitro device regulations.
New Borderline and Classification Manual published
The European Commission have published a new Borderline and Classification manual to accompany new medical device and in-vitro device regulations.
Do I need a CE Marking if my OEM already has one?
Who is responsible for CE marking on products in the EU, the original equipment manufacturer or the original brand labeller? Both! Find out why with Obelis.
UDI designating entities: EU Commission implementing decision released
An implementation decision has been published listing the entities designated to operate the Unique Device Identification (UDI) system for EU medical devices.