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Beauty and personal care, Medical devices and healthcare, Medical devices and healthcare auto, Webinars and events

Obelis partner regulatory training: takeaways from Chemron FDA Korea

An interview with Sarah You about her experience in following one of our expert’s professional trainings on EU Regulations and the insights she gained from it.

January 24, 2023
Siana Slavova 2023-01-24T12:45:38+01:00
Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto, News

What manufacturers need to know about the new extensions for legacy devices

There was a general agreement between the Council of the EU representing the EU Member States and the European Commission to extend the transitional period (legacy period) to the Medical Devices Regulation (MDR). Read all the details in our article!

January 23, 2023
Siana Slavova 2023-01-23T13:21:35+01:00
Medical devices and healthcare, Medical devices and healthcare auto

What is new in the European Standardisation system?

To modernise the European Standardisation System, the European Commission proposed to amend the Standardisation Regulation as part of its European Standardisation Strategy of February 2, 2022. Read all the details in our article!

December 20, 2022
Siana Slavova 2022-12-20T14:27:41+01:00
Medical devices and healthcare, Medical devices and healthcare auto

European Authorised Representative (EAR) for manufacturers based in Turkey

There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!

November 17, 2022
Siana Slavova 2022-11-17T17:16:30+01:00
Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto, Technology and innovation

Post-Market Surveillance (PMS) and Vigilance: definitions and differences

Vigilance and Post-Market Surveillance definition, differences and their scope. Visit our webpage for all the details!

October 20, 2022
Siana Slavova 2022-10-20T14:58:00+02:00
Beauty and personal care, Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto, Technology and innovation

EU addresses microplastics issue with regulation proposal

The European Commission issued a proposal to restrict microplastics. The regulation will have an impact on products containing those substances. Read more!

October 18, 2022
Siana Slavova 2022-10-18T17:54:00+02:00
Medical devices and healthcare, Medical devices and healthcare auto

What are the effects of the implementation of MDR on the EU medical device market?

Discover the effects of the implementation of MDR on the EU medical device market and the most relevant challenges in our new article!

September 15, 2022
Marketing 2022-09-15T15:19:15+02:00
Medical devices and healthcare, Medical devices and healthcare auto

MDR: Notice to Manufacturers for Implementation

Medical devices that have obtained CE Certificate under the MDD 93/42/EEC can circulate in the EU market. Learn the conditions here!

August 31, 2022
Marketing 2022-08-31T15:38:54+02:00
Medical devices and healthcare, Medical devices and healthcare auto, Webinars and events

Webinar: IVDR vs IvDO

Join our latest Webinar about the EU IVDR vs. the Swiss IVDO.
Watch the recording to discover all the details from our expert!

August 16, 2022
Marketing 2022-08-16T15:21:55+02:00
Beauty and personal care, Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto

HPRA alert on dangerous Melanotan 2 in self-tanning products

On June 27, 2022, the Health Products Regulatory Authority (HPRA) published an alert about the serious health risks linked to the substance Melanotan 2. Read all the details!

July 29, 2022
Marketing 2022-07-29T12:41:52+02:00

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