Obelis

★★★★★ 4.2 / 5

**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**
* Acts as EU Authorized Representative (EAR) for non-EU manufacturers of medical devices and in-vitro diagnostics, 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, EUDAMED registration, technical file review, and free sales certificates.
* 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, assisting with compliance to 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**
* Registered address in Brussels, Belgium.

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 regulatory requirements across various sectors. For medical devices and IVDs, they manage essential compliance tasks, including EUDAMED registration and technical documentation. For cosmetics, they fulfill the critical role of the EU Responsible Person, overseeing product safety, PIF compilation, and CPNP notifications. Their expertise extends to general consumer products under the GPSR, toys, food supplements, and motor vehicles, offering tailored representation and compliance checks. Training services are also available to equip client teams with the necessary knowledge for navigating EU regulations.

• Non-EU manufacturers seeking EU market access.
• Companies requiring an EU Authorized Representative or Responsible Person.
• Producers of medical devices, cosmetics, toys, food supplements, and general consumer products.

• Acts as a direct representative and point of contact.
• Provides ongoing compliance monitoring and management.
• Offers tailored regulatory training and resources.

• EU Authorized 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, safety, formula).

• Best when requiring a legally established EU entity for representation.
• Most effective for products targeting the European Union market.

HQ: Brussels, BE

Languages: English, French, Dutch

Timezones: Europe/Brussels

Claim status: Listed

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)

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