European Commission announce first four notified body designations and first CE certificate awarded under Medical Device Regulation 2017/745/EU.
Medical devices and healthcare
Brexit preparedness in case of a no-deal scenario
European Commission published its 6th communication on preparedness for Brexit for manufacturers of medical devices inside Europe and the UK.
UK Government publishes EU Exit Regulation for Medical Devices
UK government prepares for Brexit with new UK Medical Device Regulation based on retained EU law. It includes the definition of the new UK Responsible Person.
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.
Brexit & EU product legislation: What to expect?
How to Brexit-proof your market placement and compliance strategy for cosmetic products, medical devices, and in vitro devices in the European Union.
Person Responsible for Regulatory Compliance. A star is born!
Person Responsible for Regulatory Compliance: unveiling its meaning and role under the MDR.
The Basic GMDN membership is made available as a free service
Global Medical Device Nomenclature agency have announced basic membership as a free service to all users. Find out how to join and how it works.