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IVD's, Medical devices and healthcare auto, News

26 September 2024: last call for manufacturers of legacy devices

Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.

August 28, 2024
Giada Rosignoli 2024-08-28T11:21:44+02:00
A medical device placed on a table
Medical devices and healthcare, Medical devices and healthcare auto, News

How to carry out clinical investigations of medical devices in the EU

To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.

June 24, 2024
Dimitra Kagioglou 2024-06-24T15:45:47+02:00
Obelis booth at a trade show with attendees
Events, Medical devices and healthcare, Medical devices and healthcare auto, News

Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations

Obelis Group at Arab Health 2024 – Here is a successful story in medical device regulations

January 25, 2024
Dimitra Kagioglou 2024-01-25T17:04:50+01:00
Black CE mark on paper
Beauty and personal care, Consumer goods, Industrial and mechanical, Medical devices and healthcare, Medical devices and healthcare auto, Technology and innovation

What is CE Marking?

A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.

April 26, 2023
Marketing 2023-04-26T14:40:53+02:00
A woman showing a Covid test
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
Dimitra Kagioglou 2023-02-24T12:30:23+01:00
A picture of different plastic packaging
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
Dimitra Kagioglou 2023-01-23T16:47:11+01:00
Medical equipment
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
Dimitra Kagioglou 2023-01-23T13:21:35+01:00
A person using a laptop
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
Dimitra Kagioglou 2023-01-09T15:15:32+01:00
Technology processes
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
Dimitra Kagioglou 2022-12-20T14:27:41+01:00
A clean medical room
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
Dimitra Kagioglou 2022-12-07T16:20:48+01:00

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  • Industries
    • Medical
      • Medical Devices
      • In-Vitro Diagnostics
      • Aesthetic Devices
    • Cosmetics
      • Cosmetic Products
    • Food Supplements
      • Food Supplements Products
    • Other Products
      • Electronics
        • Electromagnetic Compatibility
        • Low-Voltage Products
        • Radio Equipment
      • General Products
      • Toys and children’s products
      • Construction Products
      • Machinery
      • Motor Vehicles
      • Equipment for Explosive Atmospheres (ATEX)
      • Pressure Equipment
      • Personal Protective Equipment (PPE)
    • Technology & Innovation
      • Horizon 2020
      • Horizon Europe
  • Services
    • Medical
      • EU Authorised Representative
      • EU Product Registration
      • Legal representation for clinical investigation
      • National Registration
      • EUDAMED Registration
      • Free Sales Certificate (FSC)
      • Technical File Review
      • Interruption of Supply Notification
      • Derogation for expired CE Certificates
      • GMDN and EMDN codes research
      • Registration of COVID tests
      • Notified Body Selection and Application
      • Quality Management System support
      • Testing for Medical Devices
      • Consultancy
      • Trainings
    • Cosmetics
      • EU Responsible Person
      • Formulation Review
      • Labelling Review
      • Product Information File
      • Safety Assessment
      • Lab Testing
      • CPNP Notification
      • Post-Market Surveillance
      • Packaging Recycling Symbols
      • Trainings
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