What Effectum CH-REP does

Effectum CH-REP AG is a Swiss regulatory services firm that acts as the legally required Swiss Authorized Representative (CH-REP, Schweizer Bevollmächtigter) for medical device manufacturers based outside Switzerland. The company is a brand under the parent entity QUNIQUE AG (CHE-230.350.138, headquartered at Bahnhofweg 17, Wohlen), with operational contact at Kirchgasse 11, Olten. Founded in 2017, the firm was structured to address the regulatory gap created by the May 26, 2021 entry into force of the Swiss Medical Devices Ordinance (MedDO SR 812.213), which mandates that non-Swiss manufacturers not covered by a third-country or mutual recognition agreement appoint a CH-REP in order to sell into Switzerland.

Its core offering combines four integrated capabilities: (1) CH-REP legal representation, including registration with Swissmedic, incident and complaint reporting, and guaranteed access to technical documentation; (2) provision of an in-house Person Responsible for Regulatory Compliance (PRRC) as required under EU MDR; (3) outsourced quality management systems aligned with ISO 13485; and (4) technical documentation review. Notably, Effectum also acts as legal manufacturer (rechtlicher Hersteller) on behalf of clients, jointly assuming product liability risk and requiring inclusion in the client's liability insurance — a structural differentiator from pure-representative competitors. Services cover medical device Classes I through III and IVD Classes A through D, with Class III / IVD Class D mandates accepted only in exceptional cases after detailed review.

The business operates a sales-led, quote-based go-to-market targeting a single customer segment (non-Swiss medical device manufacturers) within a single geography (Switzerland/DACH). Pricing is annual subscription-based and varies by number of technical documentations, EMDN/GMDN/UMDNS codes, and product risk class. Distribution is direct, driven by a structured four-step process (offer, NDA, technical documentation review, contract signing) initiated through the firm's website inquiry form. The firm has 11–50 employees, is privately held, has no disclosed funding, and shows no M&A, partnership, or public-market activity in the source data.

Name

Effectum CH-REP

Legal name

QUNIQUE AG

Website

https://effectum-chrep.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Effectum CH-REP AG is a Swiss regulatory services firm that acts as the legally required Swiss Authorized Representative (CH-REP) for non-Swiss medical device manufacturers seeking Swiss market access under MedDO and EU MDR/IVDR, providing PRRC, ISO 13485 QMS, and legal manufacturer services on an annual mandate basis.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Medical device regulation
• Swiss Authorized Representative
• Regulatory affairs services
• ISO 13485 compliance
• Medical device registration

Headquarters

HQ city

Olten

HQ country

Switzerland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Swiss Bevollmächtigter (CH-REP) Mandate Services: Fees charged for acting as Swiss Authorized Representative for medical device manufacturers. The company jointly assumes risk as legal manufacturer and provides PRRC, technical documentation access, Swissmedic cooperation, incident reporting, and compliance monitoring services. Pricing is quote-based, dependent on number of technical documentations and product risk classes (I, IIa, IIb, III, A-D for IVDs).

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Effectum CH-REP AG acts as the legally mandated Swiss Authorized Representative (Schweizer Bevollmächtigter / CH-REP) for non-Swiss medical device and in-vitro diagnostic (IVD) manufacturers, enabling them to legally place products on the Swiss market under MedDO SR 812.213. Services include provision of an in-house PRRC, outsourced ISO 13485 quality management systems, technical documentation review, Swissmedic registration, vigilance and incident reporting, post-market surveillance, and shared legal-manufacturer risk assumption with liability insurance coverage.

Product overview

Effectum CH-REP AG provides a unified regulatory services offering centered on Swiss Authorized Representative (CH-REP) services for medical device manufacturers outside Switzerland. As a single integrated service, they offer outsourced quality management systems (ISO 13485), technical documentation review, and act as legal manufacturer with shared risk responsibility. The company also provides a Person Responsible for Regulatory Compliance (PRRC), handles Swissmedic registrations, and manages incident/complaint reporting for Class I through III medical devices and IVD products (Classes A through D).

Differentiator

Problem solved

Functional benefit

Products and services

• Swiss Authorized Representative (CH-REP) Services Legal representation services for non-Swiss medical device and IVD manufacturers, acting as the required Schweizer Bevollmächtigter to enable market access in Switzerland under MedDO and EU MDR/IVDR frameworks. Includes PRRC provision, Swissmedic registration, incident and complaint reporting, vigilance, and guaranteed access to technical documentation copies.
• Outsourced Quality Management Systems (ISO 13485) Externalized quality management system services for medical devices built and maintained according to ISO 13485 standards, bundled with the CH-REP mandate to ensure continuous compliance across the product lifecycle.
• Technical Documentation Review Verification and review of complete technical documentation for medical devices and IVDs to confirm compliance with Swiss regulatory requirements and EU MDR/IVDR alignment prior to market entry.
• Legal Manufacturer Services with Liability Coverage Effectum CH-REP AG assumes the role of legal manufacturer (rechtlicher Hersteller) on behalf of clients, sharing product liability risk and maintaining comprehensive liability insurance coverage as part of the mandate.

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators2 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Medidee Services: Swiss-headquartered medical device regulatory affairs and quality compliance consulting firm offering CH-REP, EU AR, ISO 13485 QMS, and clinical evaluation services. Closest direct competitor given shared Swiss base, full-service regulatory mandate portfolio, and target customer overlap with non-Swiss manufacturers seeking market access.
• Qserve Group: Netherlands-based medical device regulatory consulting firm providing EU AR services, regulatory strategy, clinical evaluation, and ISO 13485 QMS support. Directly comparable business model focused on regulatory representation for non-EU manufacturers, though operating across EU rather than Switzerland specifically.
• Medical Device Safety Service (MDSS): Germany-based regulatory service provider specializing in EU Authorized Representative mandates for non-EU medical device manufacturers under MDR/IVDR. Directly comparable service offering and customer base, focused exclusively on regulatory representation services similar to Effectum's CH-REP model.
• Johner Institute: German-speaking medical device regulatory and quality compliance consultancy providing EU AR, technical documentation, and ISO 13485 services to manufacturers. Comparable business model, target customer segment, and DACH regional overlap make it a meaningful peer for cross-border mandate opportunities.

Broad incumbents

• Emergo by UL: Global regulatory affairs and quality assurance consulting firm acquired by UL, offering EU AR, CH-REP, and broader market access services across medical devices and IVDs. Significantly larger than Effectum with broader geographic footprint, but overlaps materially in the medical device regulatory representation niche.
• TÜV SÜD Product Service: Large global testing, inspection, and certification body offering notified body services, ISO 13485 certification, and regulatory consulting for medical devices. While far broader in scope, TÜV SÜD competes for adjacent services and is a potential partner or competitor in the Swiss regulatory services market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Effectum CH-REP