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Medical devices and healthcare, News

New legacy period for medical devices is official: automatic extensions and derogation for expired certificates

To prevent market disruptions and give manufacturers enough time to certify their medical devices under…

March 21, 2023
Simona Varrella 2023-03-21T11:02:44+01:00
Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto

Covid tests under IVDR – How to sell them on the EU market?

The new EU Regulation on in vitro diagnostic devices (IVDR), applicable since May 26, 2022, affected the classification and compliance process of COVID-19 tests.

February 24, 2023
Siana Slavova 2023-02-24T12:30:23+01:00
Beauty and personal care, Consumer goods, News

Endocrine Disruptors — The revision of the CLP Regulation

The EU proposal aims to introduce new hazard classes based on scientific criteria for endocrine disruptors as well as other chemicals which can accumulate in living organisms or enter the water cycle.

February 6, 2023
Siana Slavova 2023-02-06T16:03:29+01:00
Events, News

Meet Obelis’ Customer Care Department

In addition to our Customer Success Department, Obelis has recently introduced a new client-focused Department: Customer Care. Read more here!

January 31, 2023
Siana Slavova 2023-01-31T11:17:54+01:00
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, Industrial and mechanical, Medical devices and healthcare auto

Upcoming restrictions for single-use plastic packaging (PFAS) in Belgium

In November 2022, the Belgian government notified the EU of a draft Royal Decree to limit the placing on the market of single-use plastic products. Read all the details in our article!

January 23, 2023
Siana Slavova 2023-01-23T16:47:11+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 auto, Webinars and events

Webinar: EUDAMED Actor & Device registration

Register and learn all the details about EUDAMED, the European database for medical devices and In-vitro diagnostics!!

January 9, 2023
Siana Slavova 2023-01-09T15:15:32+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 auto, Webinars and events

Seminar: Placing Medical Devices and In-Vitro Diagnostic Devices on the Union Market (EU) – News and Challenges

Register for our new live webinar about MDR and IVDR! On December 19, at 3:00 pm (Beijing Time), in collaboration with TÜV SÜD and AKRA TEAM GmbH!

December 7, 2022
Siana Slavova 2022-12-07T16:20:48+01:00

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