Your medical technology gateway for Switzerland and the European Union
Market access Switzerland Swiss authorized representative according to the Medical Devices Regulation
About us
About us
About us
Any manufacturer not based in Switzerland who wishes to place their medical products on the market in Switzerland must appoint an authorized representative within Switzerland. The duties of a Swiss authorized representative are essentially similar to those of an EU authorized representative.
After commissioning, you will have a Swiss representative and an agent towards the competent Swiss supervisory authority Swissmedic. This covers liability for defective products.
Services
Position of the legal structure for Switzerland
Position of the legal structure for Switzerland
Position of the legal structure for Switzerland
Checking compliance with registration regulations
Checking compliance with registration regulations
Checking compliance with registration regulations
Cooperation with the authorities on corrective measures and product testing
Cooperation with the authorities on corrective measures and product testing
Cooperation with the authorities on corrective measures and product testing
Reporting incidents and complaints
Reporting incidents and complaints
Reporting incidents and complaints
Market access EU External Responsible Person for regulatory requirements according to Art. 15 MDR (PRRC)
In the EU, a "Responsible Person for Regulatory Compliance according to Art. 15 MDR" is required for the placing on the market of medical devices. According to EU Directive 2003/361/EC, companies with fewer than 50 employees and an annual balance sheet of a maximum of 10 million euros may utilize an external PRRC. They are exempt from the obligation to employ a PRRC themselves.
Market access without a Swiss establishment
Market access without a Swiss establishment
Market access without a Swiss establishment
Official representation to Swissmedic
Official representation to Swissmedic
Official representation to Swissmedic
ATZ Healthcare PRRC-Package EU
Your PRRC – MDR-compliant & legally secure
Position of the Responsible Person for Regulatory Requirements pursuant to Art. 15 MDR (PRRC).
Your PRRC – MDR-compliant & legally secure
Position of the Responsible Person for Regulatory Requirements pursuant to Art. 15 MDR (PRRC).
Your PRRC – MDR-compliant & legally secure
Position of the Responsible Person for Regulatory Requirements pursuant to Art. 15 MDR (PRRC).
Product inspection according to the Quality Management System (QMS)
Inspection of products according to a quality management system before they are brought to market;
Product inspection according to the Quality Management System (QMS)
Inspection of products according to a quality management system before they are brought to market;
Product inspection according to the Quality Management System (QMS)
Inspection of products according to a quality management system before they are brought to market;
Maintenance of technical documentation in accordance with MDR
Management and updating of the technical documentation and the declaration of conformity;
Maintenance of technical documentation in accordance with MDR
Management and updating of the technical documentation and the declaration of conformity;
Maintenance of technical documentation in accordance with MDR
Management and updating of the technical documentation and the declaration of conformity;
Post-Market Surveillance according to MDR
Conducting market surveillance after placing on the market (Post-Market Surveillance);
Post-Market Surveillance according to MDR
Conducting market surveillance after placing on the market (Post-Market Surveillance);
Post-Market Surveillance according to MDR
Conducting market surveillance after placing on the market (Post-Market Surveillance);
Vigilance and Reporting System according to MDR
Fulfilling reporting obligations to authorities in the event of serious incidents.
Vigilance and Reporting System according to MDR
Fulfilling reporting obligations to authorities in the event of serious incidents.
Vigilance and Reporting System according to MDR
Fulfilling reporting obligations to authorities in the event of serious incidents.
Our Vision
Our Vision
Our Vision
EU Representative according to MDR
In the European Union, any foreign manufacturer wishing to market their devices there is required to be represented by an authorized representative (EC REP) with a physical office in one of the member states. ATZ Healthcare takes on the representation of your company towards the authorities and registers your medical device in the relevant IT system prior to marketing.
ATZ Healthcare installs the structure of the authorized representative according to MDD/MDR and IVDD/IVDR. With the implementation of the MDR and IVDR, the authorized representative is considered an economic operator and is jointly liable with the manufacturer for compensation claims.
Do you want to market your medical products in the European Union? After the contract is signed, ATZ Healthcare will review your technical documentation. This ensures that your documentation complies with regulations. Finally, your medical products will be registered.
Depending on the classification of the medical device, the type of verification may differ. For Class I devices, the original manufacturer must declare conformity with the MDR/IVDR themselves. For Class II and III, a notified body is necessary, and only after approval (CE certificate) can the medical devices be registered.
The authorized representative in the European Union can also be referred to as EC REP, EUAR, CE REP, EAR, and also as EU REP. All these terms mean the authorized EU representative.
Market access without a Swiss establishment
Market access without a Swiss establishment
Market access without a Swiss establishment
Official representation to Swissmedic
Official representation to Swissmedic
Official representation to Swissmedic
ATZ Healthcare Authorized Representative MDR Package EU
ATZ Healthcare Authorized Representative MDR Package EU
EU-compliant legal structure
Stellung der rechtlichen Struktur für die EU
EU-compliant legal structure
Stellung der rechtlichen Struktur für die EU
EU-compliant legal structure
Stellung der rechtlichen Struktur für die EU
Official labeling information according to EU regulations
Use of the name and registered address for all labeling on their product
Official labeling information according to EU regulations
Use of the name and registered address for all labeling on their product
Official labeling information according to EU regulations
Use of the name and registered address for all labeling on their product
Contact address for EU authorities
Official contact address for EU regulatory authorities
Contact address for EU authorities
Official contact address for EU regulatory authorities
Contact address for EU authorities
Official contact address for EU regulatory authorities
Examination of conformity & technical documentation
Examination of the declaration of conformity and the technical documentation
Examination of conformity & technical documentation
Examination of the declaration of conformity and the technical documentation
Examination of conformity & technical documentation
Examination of the declaration of conformity and the technical documentation
First product registration in the EU
Preparation and registration of the first product in the EU electronic system
First product registration in the EU
Preparation and registration of the first product in the EU electronic system
First product registration in the EU
Preparation and registration of the first product in the EU electronic system
Support for administrative communication
Support in communication between the responsible authority and the manufacturer
Support for administrative communication
Support in communication between the responsible authority and the manufacturer
Support for administrative communication
Support in communication between the responsible authority and the manufacturer
Consultation on EU registration
Consultation on registration
Consultation on EU registration
Consultation on registration
Consultation on EU registration
Consultation on registration
Do you have questions about our products or services?
Our team is happy to assist you personally and competently. We will get back to you as soon as possible.
Do you have questions about our products or services?
Our team is happy to assist you personally and competently. We will get back to you as soon as possible.
Do you have questions about our products or services?
Our team is happy to assist you personally and competently. We will get back to you as soon as possible.