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A professional uses an ultrasound machine
Medical devices and healthcare, Medical devices and healthcare auto

A reinforced role for the European Medicines Agency (EMA)

The EU regulators agreed to introduce a new set of tools to improve the EU health security coordination before and during crises by reinforcing the management of disruptions due to the scarcity of medicinal products. Want to know more? Visit our page!

November 22, 2021
Marketing 2021-11-22T16:11:09+01:00
A professional uses an ultrasound machine
Medical devices and healthcare, Medical devices and healthcare auto

Cobalt in medical devices: French CA publishes a Q&A document

The French competent authority (ANSM) has published information for medical devices containing COBALT. The ANSM informs manufacturers that as of October 1, 2021, cobalt will need to be clasified differently. Want to know more? Visit our page!

November 22, 2021
Marketing 2021-11-22T16:02:42+01:00
Medical devices and healthcare, Medical devices and healthcare auto, Webinars and events

MEDICA 2021: Obelis Team Was There!

We met with over 400 manufacturers from more than 50 countries in MEDICA’s halls. Here are the latest news and insights we got from medical manufacturers.

November 19, 2021
Marketing 2021-11-19T14:50:14+01:00
A picture of lit candle
Consumer goods, Medical devices and healthcare, Medical devices and healthcare auto

Requirements for Legacy Devices under the MDR as of May 26, 2021

In this article we give you an overview about the MDR requirements that a legacy device must met to be considered compliant.

October 28, 2021
Marketing 2021-10-28T14:38:51+02:00
A professional uses an ultrasound machine
Medical devices and healthcare, Medical devices and healthcare auto

Use of Octylphenol ethoxylate (Triton-X-100) banned in medical devices and IVDs

The Commission Regulation (EU) 2020/2160 has restricted the use of Octylphenol ethoxylate in Medical Devices and In-Vitro Diagnostic Medical Devices from December 22, 2023, onwards. Want more details? Visit our page!

October 27, 2021
Marketing 2021-10-27T12:43:41+02:00
A professional uses an ultrasound machine
Medical devices and healthcare, Medical devices and healthcare auto

Legacy Devices and Certificates: Updates from BSI

The BSI announced in June of 2021 updates concerning certificates issued for medical devices. Do you want to know how these changes will affect manufacturers and their industries? Visit Our Website.

September 30, 2021
Marketing 2021-09-30T09:39:58+02:00
A professional uses an ultrasound machine
Medical devices and healthcare, Medical devices and healthcare auto

French CA issues procedure deal with risks of rupture of essential medical devices and IVDs.

The French CA together with the ANSM has published a management procedure to support the market operators and prevent a shortage of medical devices and in- vitro diagnostic devices.

September 30, 2021
Marketing 2021-09-30T08:42:56+02:00
Medical devices and healthcare, Medical devices and healthcare auto, Webinars and events

WEBINAR: EU- SWISS MRA LATEST

Medical device trade is affected by MDR and lack of MRA update. Find out all the details!

September 2, 2021
Marketing 2021-09-02T09:30:23+02:00
A professional uses an ultrasound machine
Medical devices and healthcare, Medical devices and healthcare auto

Italian authorities confirm: Air purifiers are not medical devices

The Italian Ministry of Health clarified the proper classification of air purifiers and air decontamination systems, as well as their intended use. Find out all the details here!

August 25, 2021
Marketing 2021-08-25T13:57:13+02:00
Natural cosmetic products photoshoot
Beauty and personal care, Medical devices and healthcare, Medical devices and healthcare auto

New Spanish cosmetic guidance: microbiologically safe cosmetic products

The AEMPS in collaboration with STANPA published a new guide to assist in formulating and manufacturing safe raw materials and cosmetic products. More information can be found here!

August 25, 2021
Marketing 2021-08-25T13:33:51+02:00

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© obelis.net | lennarthorst.com
  • 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 Compliance Support
  • Services
    • Medical
      • European Authorised Representative (EAR)
      • 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 for Medical Devices
      • Trainings
    • Cosmetics
      • EU Responsible Person for Cosmetics
      • Formulation Review
      • Labelling Review
      • Product Information File
      • Safety Assessment
      • Lab Testing
      • CPNP Notification
      • Post-Market Surveillance
      • Packaging Recycling Symbols
      • Canadian Safety Evidence Compilation
      • Canadian Formula and Label Review
      • Canadian Responsible Person
      • Canadian Digital Contact Point
      • Canadian Incident Reporting
      • Trainings
    • Food Supplements
      • Food supplements review
    • Other Products
      • Electronics
      • General Products
      • Toys
      • Market Surveillance & Compliance of Products
      • Construction Products
      • Equipment for Explosive Atmospheres (ATEX)
      • Machinery
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      • Pressure Equipment
      • Motor Vehicles
    • More Services
      • General Data Protection (GDPR)
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      • Creation of Regulatory Content
      • GS Mark Certification
  • Locations
    • Switzerland
    • United Kingdom
    • United States
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    • Medical Devices – MDlaw.eu
    • Cosmetics – COSlaw.eu
    • Other Products – PRODlaw.eu
  • News
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Schedule a call
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