The latest survey for medical device community on the status of valid/new/withdrawn CE Certificates as well as on the changes in the NB personnel.
Medical devices and healthcare
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?
1 YEAR UNTIL MDR APPLICATION: How to prepare for a transition to new requirements?
With 12 months to go until European Medical Device Regulation 2017/745 comes into effect in May 2020, we look at how to prepare your products for compliance.
Do I need an EAR if I have a Notified Body?
Though both are involved in the EU Compliance process and CE Marking, a European Authorized Representative and a Notified Body are not mutually exclusive bodies. Both have roles unique to themselves throughout the EU Compliance procedure. In order to clear up a few common misconceptions regarding European Authorized Representatives (EAR) and Notified Bodies (NB), this blog will outline the definitions and roles of each.