Obelis
Obelis Group
★★★★★
4.2
/ 5
•
20 reviews
Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for Medical Devices, Cosmetics, Toys, Food Supplements, and other industries across the EU, UK, US, Switzerland, and Canada.
Obelis Group is a leading regulatory compliance consultancy dedicated to helping businesses navigate complex international regulations. With a strong focus on the European Union, United Kingdom, United States, and Switzerland, Obelis provides expert guidance for market access across a wide range of industries, including Medical Devices, In-Vitro Diagnostics, Cosmetics, Toys, Food Supplements, and products subject to the General Product Safety Regulation (GPSR). Their services encompass acting as an Authorised Representative (AR) and Responsible Person (RP), ensuring product compliance, managing technical documentation, handling regulatory notifications, and facilitating communication with authorities. Obelis offers tailored solutions for CE marking, EUDAMED registration, formula review, labelling compliance, and claims verification, among others. With a commitment to simplifying regulatory journeys, Obelis provides comprehensive support from product development to post-market surveillance. They offer flexible training programs and practical resources to empower your team with the knowledge needed to succeed in global markets. Obelis ensures that your products meet all legal requirements, safeguarding consumer safety and building brand trust.
About
**Who they are**
Obelis Group is a regulatory compliance partner specializing in market access for various industries across the EU, UK, US, Switzerland, and Canada. They focus on ensuring products meet stringent regulatory requirements.
**Expertise & scope**
* EU Authorized Representative (EAR) services for medical devices and in-vitro diagnostics, managing compliance and official communications.
* General Product Safety Regulation (GPSR) compliance support for consumer products not covered by sector-specific legislation.
* Toys compliance and representation services for the EU and UK, ensuring adherence to safety directives.
* Food supplements compliance, including formula review, labeling, claims verification, and product registration for EU, UK, and Swiss markets.
* EU Responsible Person (RP) services for cosmetics, ensuring compliance with EU Cosmetics Regulation (EC) No 1223/2009, including PIF compilation, safety assessments, and CPNP notifications.
* Authorised Representative services for motor vehicles, ensuring compliance with EU automotive regulations.
* Regulatory training programs for cosmetics, medical devices, and IVDs, available online or in-house.
**Reputation / proof points**
* Established presence in Brussels, Belgium, serving as a registered office address.
* Offers practical resources and regulatory tools to simplify compliance journeys.
Obelis Group is a regulatory compliance partner specializing in market access for various industries across the EU, UK, US, Switzerland, and Canada. They focus on ensuring products meet stringent regulatory requirements.
**Expertise & scope**
* EU Authorized Representative (EAR) services for medical devices and in-vitro diagnostics, managing compliance and official communications.
* General Product Safety Regulation (GPSR) compliance support for consumer products not covered by sector-specific legislation.
* Toys compliance and representation services for the EU and UK, ensuring adherence to safety directives.
* Food supplements compliance, including formula review, labeling, claims verification, and product registration for EU, UK, and Swiss markets.
* EU Responsible Person (RP) services for cosmetics, ensuring compliance with EU Cosmetics Regulation (EC) No 1223/2009, including PIF compilation, safety assessments, and CPNP notifications.
* Authorised Representative services for motor vehicles, ensuring compliance with EU automotive regulations.
* Regulatory training programs for cosmetics, medical devices, and IVDs, available online or in-house.
**Reputation / proof points**
* Established presence in Brussels, Belgium, serving as a registered office address.
* Offers practical resources and regulatory tools to simplify compliance journeys.
Additional information
Obelis Group provides comprehensive regulatory support across multiple product categories, including medical devices, cosmetics, toys, food supplements, and motor vehicles. They emphasize a tailored approach, customizing training programs and compliance strategies to a client's specific business model, product type, and regulatory experience. Their services are designed to streamline market access by ensuring adherence to complex regulations like the EU Medical Device Regulation (MDR), In-Vitro Diagnostic Regulation (IVDR), General Product Safety Regulation (GPSR), and EU Cosmetics Regulation. Obelis acts as a crucial point of contact for EU authorities, managing technical documentation, post-market surveillance, and incident reporting, enabling manufacturers to operate with confidence in the European market.
Key Highlights
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Acts as EU Authorized Representative (EAR) for medical devices and in-vitro diagnostics, overseeing compliance and official communications.
Source
“As your EAR, we will oversee all compliance and official communications, allowing you to focus on growing your business.”
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Provides EU Responsible Person (RP) services for cosmetics, ensuring compliance with EU Cosmetics Regulation (EC) No 1223/2009.
Source
“Obelis acts as your EU Responsible Person, ensuring your cosmetic products comply with all requirements under the EU Cosmetics Regulation.”
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Offers support for the EU General Product Safety Regulation (GPSR) for consumer products not covered by sector-specific legislation.
Source
“Obelis provides full regulatory support to ensure your products meet GPSR 2023/988 requirements in the EU.”
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Specializes in compliance and representation services for toys in the European Union and United Kingdom.
Source
“Obelis supports manufacturers and brand owners in achieving full toys compliance conformity, acting as your Authorised Representative in the European Union and in the UK”
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Provides regulatory compliance services for food supplements, covering formula review, labeling, and product registration for EU, UK, and Switzerland.
Source
“Our services cover formula review, labelling compliance, claims verification, product registration, and regulatory notifications, ensuring your food supplements are compliant, safe, and ready for successful market entry.”
Certifications & Trust Signals
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Established presence in Brussels, Belgium, serving as a registered office address.
Source
“Registered addressBd Général Wahis 53B-1030 Brussels, BelgiumRegistered office addressBoulevard Brand Whitlock 30B-1200 Brussels, Belgium”
Buyer Snapshot
Best for
- Non-EU manufacturers seeking EU market access.
- Companies requiring specialized regulatory representation.
- Businesses needing compliance support for medical devices, cosmetics, toys, food supplements, or vehicles.
How engagement typically works
- Partnership for regulatory compliance.
- Proactive guidance and support.
- Tailored training and consultation.
Typical deliverables
- EU Authorized Representative appointment.
- Responsible Person designation for cosmetics.
- Technical documentation review and organization.
- Product registration and notification.
- Labeling and formula compliance checks.
- Post-market surveillance and vigilance reporting.
Good to know
- Best when requiring EU, UK, US, Switzerland, or Canada market access support.
- Most effective for products regulated under MDR, IVDR, GPSR, and Cosmetics Regulation.
HQ:
Brussels, BE
Languages:
English, French, Dutch
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
BE, NL, DE, FR, IE, ES, IT
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 8,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Belgium
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Belgium
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Onboarding involves understanding the client's business model, product type, and regulatory experience to tailor training and compliance strategies. Specific steps for market entry include appointing an EU Authorized Representative or Responsible Person, technical file review, compliance verification, and managing official communications with authorities.
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
