Find out more about the technical requirements and approval process for motor vehicles under EU regulation 2018/46/EC entering effect in September 2020.
Consumer goods
The CPNP Notification Process – Step by step
A simple guide to bringing your cosmetics products though the Cosmetics Products Notification Portal for total European Market compliance.
MDR in few words
A brief overview of the best path for ensuring full compliance with MDR 2017/745 and the implications it has for medical device manufacturers in Europe.
Upcoming event: RMD + CRCC 2019 in Brussels
Obelis invites you to its 4th ERPA Annual Congress on Regulations and Compliance for Cosmetics and EAAR Annual MDR Conference on October 28-29, 2019.
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.
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.
‘Free from’ claims – clarification of application
Danish authorities ask for clarification on processes for 'free from' claims for cosmetics products on the European market.
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.
What is Eudamed?
Learn more about the new European Databank on Medical Devices and its role in strengthening market surveillance and transparency across the EU.