Person Responsible for Regulatory Compliance: unveiling its meaning and role under the MDR.
News
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.
Annual Team-NB Survey: 30% increase in CE Certificates
The latest survey for medical device community on the status of valid/new/withdrawn CE Certificates as well as on the changes in the NB personnel.
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.
What kind of testing do I need to do to register my cosmetics in the EU?
Find out what tests and other compliance factors may affect your cosmetic products under EU Cosmetics Regulation EC 1223/2009. Our EU experts are here to help.
Food Supplements Services launch!
Obelis launch consultancy and regulatory services for EU food supplements controlled by European directive 2002/46/EC.
Medical Device Regulation- moving towards a transition
Useful information on the introduction of the European Medical Device Regulation: timelines, strategy, and the Medical Device Coordination Group.
Obelis new interdepartmental organization
Obelis announces re-organisation of departmental structure in ongoing expansion for greater skill development and improved career path transparency.
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.