The European Commission called for the creation of expert panels to advise and support on new EU medical device and in-vitro device regulations.
Medical devices and healthcare auto
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.
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.
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.
French Competent Authority bans various types of breast implants linked to cancer
French competent authority Agence Nationale de Sécurité de Médicament et des Produits de Santé ban breast implants linked to anaplastic large cell lymphoma.
New Benefits with Obelis Monthly Plans
Obelis expands monthly plan offering to include greater round-the-clock client support and EU regulatory consulting scope.
Consequences of Non-Compliance
Full adherence to all compliance-related matters is a hugely important part of introducing a product to the European Market – or indeed maintaining its position there. Each category of CE Marking certifiable product has its own set of regulations or directives, from medical devices to personal protective equipment to toys, and electromagnetic devices to construction products and motor vehicles.
Biocompatibility: MDR and EN ISO 10993-1:2018
What does the new standard on Medical Device Regulation say.