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How to Obtain a CE Mark (for a Medical Device)
Obelis' CE marking experts walk you through the simple 7-step process for obtaining a CE marking for medical devices and accessing the European market.
I notified my own products within the CPNP
Discover the role of the Cosmetics Products Notification Portal (CPNP).
Can my Distributor act as Responsible Person
It's mandatory to appoint a Responsible Person when introducing a product to the European Market. Find out how to appoint one.
Commission’s communication campaign on MDR and IVDR – special notice to manufacturers
European Commission issues special notice to medical and in-vitro diagnostic device manufacturers to clarify scope and requirements of new EU regulations.
ECHA publishes new report on nanomaterials in the European Union
European Chemicals Agency releases a report on truthfulness of data on nanomaterials in EU cosmetics products. Download the report for free in English.
Incidents defined under the new Medical Device Regulation
Learn more about the definition and categorization of incidents as outlined by new EU medical device regulation 2017/745.
MHRA Official Guidance on How Medicines, Medical Devices and Clinical Trials Would Be Regulated If There’s No Brexit Deal
March 29th 2019 is fast approaching, and the UK is currently facing to leave the EU without a deal in place. For this reason, the UK government has been publishing technical notices for businesses and citizens to understand what to expect in a no deal scenario. We will focus on the recently published MHRA official guidance with regard to the regulation of medicines, medical devices and clinical trials in case there is no Brexit deal. Find here the most remarkable points.
The prohibition of misleading claims arising from Article 7 MDR was implemented as a criminal offence in the Netherlands
Authorities in the Netherlands classify the printing of misleading claims on labelling or instructions for use on cosmetics products a criminal offence.
Chemicals Found To Be Non-Compliant with EU Rules
German Federal Institute for Risk Assessment found 32% of ECHA-authorised substances to be non-compliant with EU Cosmetic Regulation 1223/2009.