Obelis Group Obelis Group
  • About Us
  • Careers
Get in touch
Menu Close
  • 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
      • National Registration
      • EUDAMED Registration
      • Free Sales Certificate (FSC)
      • Technical File Review
      • Derogation for expired CE Certificates
      • GMDN and EMDN codes research
      • HSC IVD List– Registration of COVID tests
      • Notified Body Selection and Negotiation
      • 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
    • Food Supplements
      • Food supplements review
    • Other Products
      • Electronics
      • General Products
      • Toys
      • Market Surveillance & Compliance of Products
      • Construction Products
      • Equipment for Explosive Atmospheres (ATEX)
      • Machinery
      • Personal Protective Equipment (PPE)
      • Pressure Equipment
      • Motor Vehicles
    • More Services
      • General Data Protection (GDPR)
      • Legal services
      • Creation of Regulatory Content
      • GS Mark Certification
  • Regions
    • EU
    • UK
    • USA
    • Switzerland
  • Platforms
    • Medical Devices – MDlaw.eu
    • Cosmetics – COSlaw.eu
    • Other Products – PRODlaw.eu
  • News

News

  • Beauty and personal care
  • Consumer goods
  • Industrial and mechanical
  • Medical devices and healthcare
  • Technology and innovation
  • Webinars and events
Beauty and personal care, Webinars and events

Webinar – MoCRA: Safety Substantiation

Book your spot for our new live webinar about Safety Substatiation for cosmetics in the US market, on September 26th

September 21, 2023
Siana Slavova 2023-09-21T11:35:56+02:00
Medical devices and healthcare, News

Facility registration under MoCRA: who has to register and how to do it

The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).

September 19, 2023
Siana Slavova 2023-09-19T14:43:41+02:00
Medical devices and healthcare, News

Good manufacturing practices (GMP) for cosmetic producers explained

The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).

September 18, 2023
Siana Slavova 2023-09-18T15:57:38+02:00
Medical devices and healthcare, News

What is safety substantiation for cosmetic products and how to obtain it?

The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).

September 15, 2023
Siana Slavova 2023-09-15T16:49:02+02:00
Medical devices and healthcare, News

From FDA facility registration to US Agent: MoCRA step-by-step for the European cosmetic industry

The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).

September 13, 2023
Siana Slavova 2023-09-13T17:11:33+02:00
Medical devices and healthcare, News

EU Regulations on Medical Devices and IVD medical devices: What is the mandate and when do manufacturers need it?

Non-EU manufacturers can sell medical devices on the European Union market only if they appoint an authorised representative (EAR). Read more!

September 7, 2023
Siana Slavova 2023-09-07T10:58:41+02:00
Beauty and personal care, Webinars and events

Webinar – Adverse event reporting for cosmetics in the US market: addressing serious incidents and reporting to the FDA

Book your spot for our new live webinar about adverse event reporting for cosmetics in the US market, on September 19th

September 6, 2023
Siana Slavova 2023-09-06T08:51:40+02:00
Medical devices and healthcare, News

What is a PLIP and why is it required under MDR?

Article 10 (16) of the MDR obliges the manufacturer to have sufficient financial coverage for potential liability of defective medical devices. Read more!

August 30, 2023
Siana Slavova 2023-08-30T11:46:44+02:00
Medical devices and healthcare, News

What documents are required for EUDAMED Actor Registration?

Articles 31 of the MDR and Article 28 of the IVDR require all manufacturers, authorised representatives, and importers to register as actors on the EUDAMED database.

August 25, 2023
Siana Slavova 2023-08-25T15:25:57+02:00
Medical devices and healthcare, News

Reusable surgical instrument, a MDR legacy device?

The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).

August 18, 2023
Siana Slavova 2023-08-18T15:33:03+02:00
Our expertise
  • 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
      • National Registration
      • EUDAMED Registration
      • Free Sales Certificate (FSC)
      • Technical File Review
      • Derogation for expired CE Certificates
      • GMDN and EMDN codes research
      • HSC IVD List– Registration of COVID tests
      • Notified Body Selection and Negotiation
      • 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
    • Food Supplements
      • Food supplements review
    • Other Products
      • Electronics
      • General Products
      • Toys
      • Market Surveillance & Compliance of Products
      • Construction Products
      • Equipment for Explosive Atmospheres (ATEX)
      • Machinery
      • Personal Protective Equipment (PPE)
      • Pressure Equipment
      • Motor Vehicles
    • More Services
      • General Data Protection (GDPR)
      • Legal services
      • Creation of Regulatory Content
      • GS Mark Certification
  • Regions
    • EU
    • UK
    • USA
    • Switzerland
  • Platforms
    • Medical Devices – MDlaw.eu
    • Cosmetics – COSlaw.eu
    • Other Products – PRODlaw.eu
  • News
Get to know us
  • About Us
  • Contact
  • Careers
  • Partners
Policies
  • Privacy Policy
  • Quality Policy
  • Terms of Business
  • Payment Policy

Obelis Group
Boulevard Brand Whitlock 30,
Brussels, 1200
Belgium
T: +32 (0)2 732 59 54
E: sales@obelis.net

The content on this website does not provide legal advice and is for information purpose only. Obelis accepts no liability for any inaccuracies or omissions in the information in its website and any decisions based on such are under the sole responsibility of the reader.

© 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
  • Services
    • Medical
      • EU Authorised Representative
      • EU Product Registration
      • National Registration
      • EUDAMED Registration
      • Free Sales Certificate (FSC)
      • Technical File Review
      • Derogation for expired CE Certificates
      • GMDN and EMDN codes research
      • HSC IVD List– Registration of COVID tests
      • Notified Body Selection and Negotiation
      • 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
    • Food Supplements
      • Food supplements review
    • Other Products
      • Electronics
      • General Products
      • Toys
      • Market Surveillance & Compliance of Products
      • Construction Products
      • Equipment for Explosive Atmospheres (ATEX)
      • Machinery
      • Personal Protective Equipment (PPE)
      • Pressure Equipment
      • Motor Vehicles
    • More Services
      • General Data Protection (GDPR)
      • Legal services
      • Creation of Regulatory Content
      • GS Mark Certification
  • Regions
    • EU
    • UK
    • USA
    • Switzerland
  • Platforms
    • Medical Devices – MDlaw.eu
    • Cosmetics – COSlaw.eu
    • Other Products – PRODlaw.eu
  • News
Get in touch
  • About Us
  • Careers

© obelis.net | lennarthorst.com