European Commission's revision of EU Machinery Directive expected in the second quarter of 2021. It's set to clarify definitions of new digital technologies.
Medical devices and healthcare
Services
Obelis safeguards your future in the European community through expert compliance, CE marking, regulatory consulting, and authorized representative services.
News
Keep updated on EU compliance and regulatory news from the medical and healthcare, cosmetics, consumer goods, technology and chemical industries and more.
Obelis UK Ltd established!
Obelis announce new Obelis UK Ltd to provide services for cosmetics manufacturers requiring a UK Responsible Person in the case of a 'no deal' Brexit.
Events
Find out how to meet the Obelis team at the next healthcare, medical device, or beauty and personal care trade fair or expo event near you.
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.
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.