Regulatory Representation and Market Access for Medical Device Manufacturers in Switzerland and EU

ATZ Healthcare AG

Egnach (CH) · Konstanz (DE)New on Amplifa

2021Founded

1–10Employees

AG (Switzerland)Legal Form

About ATZ Healthcare

ATZ Healthcare AG, based in Egnach in the canton of Thurgau, offers regulatory affairs and market access services for manufacturers of medical devices and in-vitro diagnostics (IVD). The company acts as the Swiss Authorized Representative to the regulatory authority Swissmedic and the EU Representative (EC REP/EUAR) according to MDD/MDR and IVDD/IVDR. Furthermore, ATZ Healthcare provides the External Responsible Person for regulatory compliance under Art. 15 MDR (PRRC), reviews declarations of conformity and technical documentation, manages documentation according to MDR, and assists with product registrations in EUDAMED. Other services include post-market surveillance, vigilance and reporting, and official communication with authorities. This allows the company to enable manufacturers without their own presence to gain market access in Switzerland and the EU. ATZ Healthcare was founded in 2021 and employs fewer than ten people; it maintains a branch in Germany via ATZ Healthcare GmbH in Konstanz.

Site: Egnach
Processes: Swiss Authorized Representative (Authorized representation to Swissmedic), EU Representative (EC REP/EUAR) according to MDD/MDR and IVDD/IVDR, External Responsible Person for regulatory compliance according to Art. 15 MDR (PRRC), Review of declaration of conformity and technical documentation, Maintenance/management of technical documentation according to MDR, Product registration in EU/EUDAMED, Post-Market Surveillance, Vigilance and reporting
Materials: Swiss Authorized Representative, EU Representative (MDR/IVDR), Responsible Person Art. 15 MDR
Certificates: Product testing according to QMS
Founded: 2021
Employees: 1–10
Industries: Medical Technology (Medical Devices), In-vitro Diagnostics (IVD), Health Care / Life Science, Regulatory Affairs / Compliance Consulting, B2B Professional Services

01
Consulting and legal structure placement (CH/EU)
02
Review of declaration of conformity and technical documentation
03
Product registration in EU/EUDAMED
04
Official representation to Swissmedic or EU authorities
05
Post-Market Surveillance, Vigilance, and regulatory communication

Services

MDR

Swiss Authorized Representative

Authorized representation for manufacturers not domiciled in Switzerland to Swissmedic, including assumption of associated tasks.

EC REP

EU Representative (MDR/IVDR)

Legal structure as an economic operator according to MDD/MDR and IVDD/IVDR, including labeling details and contact address for EU authorities.

PRRC

Responsible Person Art. 15 MDR

External PRRC for small companies (<50 employees, max. 10 million Euro annual turnover) according to EU Directive 2003/361/EC.

Locations

Egnach

Head Office

Konstanz

ATZ Healthcare GmbH Branch

Industries

Medical Technology (Medical Devices)In-vitro Diagnostics (IVD)Health Care / Life ScienceRegulatory Affairs / Compliance ConsultingB2B Professional Services

Additional services

Swiss Authorized Representative (Authorized representation to Swissmedic)EU Representative (EC REP/EUAR) according to MDD/MDR and IVDD/IVDRExternal Responsible Person for regulatory compliance according to Art. 15 MDR (PRRC)Review of declaration of conformity and technical documentationMaintenance/management of technical documentation according to MDRProduct registration in EU/EUDAMEDPost-Market SurveillanceVigilance and reportingOfficial communication with authoritiesConsulting for EU registrationMarket access without own presenceProduct testing according to QMS

Quality & Compliance

Product testing is carried out according to the Quality Management System (QMS) before market placement; technical documentation is continuously maintained and updated according to MDR.

Evidence	Egnach
Product testing according to QMS

History

2021
Founding of ATZ Healthcare AG