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.
**Expertise & scope**
* Appointed as EU Authorised Representative (EAR) for non-EU manufacturers of medical devices (MDs) and in-vitro diagnostics (IVDs), overseeing compliance and official communications.
* Ensures product compliance with Regulation 2019/1020, managing technical documentation and acting as a point of contact for EU authorities.
* Provides services for CE marking guidance, EUDAMED registration, technical file review, and Free Sales Certificate (FSC) issuance.
* Offers regulatory support for cosmetics, including acting as the EU Responsible Person (RP) under Regulation (EC) No 1223/2009, reviewing product formulas, compiling Product Information Files (PIF), and managing CPNP notifications.
* Supports compliance with the EU General Product Safety Regulation (GPSR – EU Regulation 2023/988) for consumer products not covered by sector-specific legislation, acting as Authorised Representative and Responsible Person.
* Provides compliance services for toys, acting as an Authorised Representative in the EU and UK, ensuring adherence to the Toy Safety Directive 2009/48/EC.
* Offers regulatory compliance services for food supplements, covering formula review, labelling compliance, claims verification, and product registration for EU, UK, and Swiss markets.
* Acts as an Authorised Representative for motor vehicles in the EU, ensuring compliance with Regulation (EU) 2018/858.
* Delivers tailored regulatory training programs for cosmetics, medical devices, and IVDs, available in-house, online, or via their platforms (COSlaw.eu, MDlaw.eu, PRODlaw.eu).
**Reputation / proof points**
* Established presence with registered office address in Brussels, Belgium.
Obelis Group is a regulatory compliance partner specializing in market access for various industries across the EU, UK, US, Switzerland, and Canada.
**Expertise & scope**
* Appointed as EU Authorised Representative (EAR) for non-EU manufacturers of medical devices (MDs) and in-vitro diagnostics (IVDs), overseeing compliance and official communications.
* Ensures product compliance with Regulation 2019/1020, managing technical documentation and acting as a point of contact for EU authorities.
* Provides services for CE marking guidance, EUDAMED registration, technical file review, and Free Sales Certificate (FSC) issuance.
* Offers regulatory support for cosmetics, including acting as the EU Responsible Person (RP) under Regulation (EC) No 1223/2009, reviewing product formulas, compiling Product Information Files (PIF), and managing CPNP notifications.
* Supports compliance with the EU General Product Safety Regulation (GPSR – EU Regulation 2023/988) for consumer products not covered by sector-specific legislation, acting as Authorised Representative and Responsible Person.
* Provides compliance services for toys, acting as an Authorised Representative in the EU and UK, ensuring adherence to the Toy Safety Directive 2009/48/EC.
* Offers regulatory compliance services for food supplements, covering formula review, labelling compliance, claims verification, and product registration for EU, UK, and Swiss markets.
* Acts as an Authorised Representative for motor vehicles in the EU, ensuring compliance with Regulation (EU) 2018/858.
* Delivers tailored regulatory training programs for cosmetics, medical devices, and IVDs, available in-house, online, or via their platforms (COSlaw.eu, MDlaw.eu, PRODlaw.eu).
**Reputation / proof points**
* Established presence with registered office address in Brussels, Belgium.
Additional information
Obelis Group provides comprehensive regulatory support, acting as a crucial link between non-EU manufacturers and EU authorities. Their services are designed to streamline market access by ensuring products meet stringent EU regulations across various sectors, including medical devices, cosmetics, toys, food supplements, and general consumer products. They emphasize proactive management of compliance obligations, including technical documentation, regulatory notifications, and post-market surveillance, enabling businesses to operate with confidence in the European market. Their training programs are customizable to address specific business needs and regulatory experience levels, offering flexible delivery methods to suit client preferences.
Key Highlights
-
Acts as EU Authorised Representative for medical devices, in-vitro diagnostics, toys, and motor vehicles.
Source
“Appointing a EU Authorised Representative (EAR) is a legal requirement for non-EU manufacturers of medical devices (MDs) and in-vitro diagnostics (IVDs).”
-
Serves as EU Responsible Person for cosmetics, ensuring compliance with Regulation (EC) No 1223/2009.
Source
“To legally place cosmetics on the EU and EEA markets, manufacturers must comply with one of the world’s strictest regulations, the EU Cosmetics Regulation (EC) No 1223/2009.”
-
Provides support for the EU General Product Safety Regulation (GPSR) for consumer products.
Source
“Obelis provides full regulatory support to ensure your products meet GPSR 2023/988 requirements in the EU.”
-
Offers regulatory training for cosmetics, medical devices, and IVDs, with flexible delivery options.
Source
“Our flexible cosmetic training and regulatory learning programmes are available via in-house, online, or via our COSlaw.eu, MDlaw.eu, and PRODlaw.eu platforms”
Certifications & Trust Signals
-
Registered office in Brussels, Belgium, serving as a central point for EU regulatory matters.
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 an EU Authorised Representative or Responsible Person.
- Businesses needing support with complex regulatory frameworks like MDR, IVDR, GPSR, and Cosmetics Regulation.
How engagement typically works
- Proactive compliance management.
- Dedicated regulatory support.
- Customized training solutions.
Typical deliverables
- EU Authorised Representative services.
- EU Responsible Person services for cosmetics.
- Technical documentation review and management.
- Regulatory notifications and registrations (e.g., EUDAMED, CPNP).
- Product compliance assessments (labeling, formula, safety).
- Customized regulatory training.
Good to know
- Best when engaging a partner for ongoing regulatory compliance and market access in the EU and other specified regions.
HQ:
Brussels, BE
Languages:
English, French, Dutch
Timezones:
Europe/Brussels
Claim 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
Engaging Obelis as an EU Authorised Representative involves appointing them to oversee compliance and official communications, organizing technical documentation, and ensuring readiness for inspections. For cosmetics, services include reviewing product formulas, compiling Product Information Files (PIF), and coordinating safety assessments. The process aims to streamline market entry and ensure ongoing adherence to EU regulations.
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
⚡ Instant booking available
Appoint an EU MDR Authorized Representative in Minutes
Compare Obelis and other vetted providers — instant pricing, no RFQ needed.
