MedNet GmbH of Münster at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
Service

MedNet GmbH

Borkstr. 10, 48163 Münster
Germany

Telephone +49 251 32266-0
Fax +49 251 32266-22
ecrep@medneteurope.com

This company is co-exhibitor of
Ministerium für Wirtschaft, Innovation, Digitalisierung und Energie des Landes Nordrhein-Westfalen

Hall map

MEDICA 2017 hall map (Hall 3): stand C80

Fairground map

MEDICA 2017 fairground map: Hall 3

Contact

David Thaler

Phone
+4925132266-0

Email
info@medneteurope.com

Visit us

Hall 3 / C80

13.11.2017

Topic

Download

18:00 - 20:00

NRW Stand Party, Hall 3, Stand C80

Visit MedNet Team at the Stand Party and have a conversation in a casual atmosphere.

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14.11.2017

Topic

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15:00 - 15:45

"EC-Rep Activities under new MDR", David Thaler, MedNet GmbH @ NRW Booth, Hall 3, Stand C80

Visit the Lecture of David Thaler, General Manager MedNet GmbH, who speaks about EC-Rep under new Medical Device Regulations". (English /Japanese presentation)

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15.11.2017

Topic

Download

13:00 - 13:45

"EC-Rep Activities under new MDR", David Thaler, MedNet GmbH @ NRW Booth, Hall 3, Stand C80

Visit the Lecture of David Thaler, General Manager MedNet GmbH, who speaks about EC-Rep under new Medical Device Regulations".

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Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Our products

Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

EC Rep for Active Implantable Medical Devices

MedNet as your Authorized Representative for active implantables acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the Active Implantable Medical Devices Directive as well as additional services regarding the marketing of your active implantables within the European Community.

MedNet Services for Active Implantable Medical Devices
 
  • fast product registrations to EU Competent Authorities.
  • guidance in the preparation of Declarations of Conformity.
  • guidance in the labeling and language requirements in Europe.
  • Incident reporting to the competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state.
  • notification services for clinical investigations.
  • application of Free Sales Certificates / Certificates of Marketability
  • provision of Certificates of product registration

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Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

EC Rep for In-Vitro Diagnostics

MedNet as your Authorized Representative for in-vitro diagnostics acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the In-Vitro Diagnostic Medical Devices Directive (98/79/EC) as well as additional services regarding the marketing of your in-vitro diagnostics within the European Community.

MedNet Services for In Vitro-Diagnostics
 
  • fast product registrations to EU Competent Authorities
  • guidance in the preparation of Declarations of Conformity
  • guidance in the labeling and language requirements in Europe
  • Incident reporting to the competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state
  • notification services for clinical investigations
  • application of Free Sales Certificates / Certificates of Marketability
  • preparation of Certificates of product registration

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Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

EC Rep for Medical Devices

MedNet as your Authorized Representative for medical devices acts as your legal entity towards the European authorities and fulfills on your behalf the obligations described in the Medical Device Directive MDD 93/42/EEC as well as additional services regarding the marketing of your medical devices within the European Community.

MedNet Services for Medical Devices
  •  fast product registrations to the EU Competent Authorities
  • guidance in the preparation of Declarations of Conformity
  • guidance in the labeling and language requirements in Europe
  • Incident reporting to the Competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state
  • notification services for clinical investigations
  • application of Free Sales Certificates or Certificates of Marketability
  • provision of Certificates of product registration

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Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

Responsible Person for Cosmetic Products

MedNet as your Authorized Representative for cosmetic products acts as your Responsible Person towards the European authorities and fulfills on your behalf the obligations described in the Cosmetic Products EC Regulation (No. 1223/2009) as well as additional services regarding the marketing of your cosmetic products within the European Community.

MedNet Services for Cosmetic Products:
  •  fast product notification to all relevant EU Competent Authorities and the European Cosmetic Products Notification Portal CPNP
  • guidance in the labeling and language requirements in Europe
  • MedNet holds the Product Information File available for review by the EU Authorities or Bodies.
  • a vigilance system according to the relevant directive
  • assistance in complaint handling
  • Certificates of product notification

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Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

Sponsor Representative for Clinical Studies

MedNet as your Sponsor Representative acts as your legal entity towards the relevant European Authorities and fulfills on your behalf the obligations as required by the relevant directives and local laws of the EU member states in which the studies will be performed.
MedNet Services for clinical studies and performance evaluations:
  • fast study notifications / registrations to EU Competent Authorities with special experience in the complex German medical devices legislation
  • guidance in the language requirements in Europe
  • Severe Adverse Events (SAE) reporting to the Competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU member state
  • notification of the Competent Authorities about the end or early termination of the clinical investigation in time

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About us

Company details

About MedNet
MedNet is a Germany-based company that deals in the international industry of medical and pharmaceutical components and services since 1990. Beside the marketing and sale of standard components and customized material solutions, MedNet provides regulatory services for manufacturers outside the European Union, marketing their medical devices, products and clinical studies within the E.U.

As your European Authorized Representative
MedNet acts as your legal entity towards the authorities while marketing your medical devices, active implantables, clinical studies or cosmetic products within the European Community, dealing with the obligations of the relevant medical directives. With our special experience in the complex european medical devices legislation, MedNet provides fast study notifications and product registrations for medical devices, active implantables, in-vitro diagnostics and cosmetic products within the EU. Therefore our experts take care of the incident reporting and preparation of Declarations of Conformity as well as the application of several other Certificates.  

As a marketing and distribution company
MedNet represents well known OEM’s from all over the world, distinguishing themselves by innovative products. Our customer base is the medical and pharmaceutical industry, but also companies producing industrial applications and worldwide markets. 

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