How to Brexit-proof your market placement and compliance strategy for cosmetic products, medical devices, and in vitro devices in the European Union.
Medical devices and healthcare auto
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.
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.
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.
MDR and IVDR Corrigenda published by the EU
EU announce first corrigenda to medical and in-vitro device regulations. Some make formal changes while others amended content. Learn more with Obelis.
Biocompatibility: MDR and EN ISO 10993-1:2018
What does the new standard on Medical Device Regulation say.
Third-Party Producers and the European Market
There are many things to consider when introducing a product to the European Market for the first time. Right at the top of that list is: What is the background of my third-party producer and are there any barriers to their components entering the market?