MedNet GmbH aus Münster auf der MEDICA 2018 in Düsseldorf -- MEDICA - Weltforum der Medizin
Dienstleister

MedNet GmbH

Borkstr. 10, 48163 Münster
Deutschland
Telefon +49 251 3226661
Fax +49 251 3226622
ecrep@medneteurope.com

Dieser Aussteller ist Mitaussteller von
Ministerium für Wirtschaft, Innovation, Digitalisierung und Energie des Landes Nordrhein-Westfalen

Hallenplan

MEDICA 2018 Hallenplan (Halle 3): Stand C80

Geländeplan

MEDICA 2018 Geländeplan: Halle 3

Ansprechpartner

Birthe Harms

Telefon
0251-32266-61

E-Mail
ecrep@medneteurope.com

Amy Quian

Area Manager Asia

Unser Angebot

Produktkategorien

  • 07  Medizinische Dienstleistungen und Verlagserzeugnisse
  • 07.15  Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen

Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen

  • 07  Medizinische Dienstleistungen und Verlagserzeugnisse
  • 07.16  Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

  • 07  Medizinische Dienstleistungen und Verlagserzeugnisse
  • 07.17  Sonstige medizinische Dienstleistungen und Verlagserzeugnisse

Unsere Produkte

Produktkategorie: Sonstige medizinische Dienstleistungen und Verlagserzeugnisse

EC Representation 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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Produktkategorie: Sonstige medizinische Dienstleistungen und Verlagserzeugnisse

Responsible Person 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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Produktkategorie: Sonstige medizinische Dienstleistungen und Verlagserzeugnisse

Sponsor for Clinical Studies

  • 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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Firmennews

Datum

Thema

Download

01.08.2018

United Kingdom’s withdrawal (Brexit) from European Union – Consequences for the distribution of your medical devices/cosmetic products

1. European Authorized Representative/Responsible Person located in UK not accepted anymore
In the Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, and Cosmetic Regulation 1223/2009, the entity act as “European Authorized Representative”/”Responsible Person” shall be established in the European Union. Authorized Representatives or Responsible Persons established in the United Kingdom will not, as from the withdrawal date, be recognized as Authorized Representatives or Responsible Persons for the purposes of the applicable Union product legislation. Therefore, manufacturers are advised to take the necessary steps to ensure that, as from the withdrawal date, their designated Authorized Representatives or Responsible Persons are established in the EU member states.

2. Notified Body located in UK not accepted as EU Notified Body anymore
Union product legislation requires Notified Bodies to be established in a member state and be designated by a member state notifying authority for performing the conformity assessment tasks set out in the relevant act of Union product legislation. Therefore, as from the withdrawal date, UK Notified Bodies will lose their status as EU Notified Bodies. As such, they will no longer be in the position to perform conformity assessment tasks as from the withdrawal date, unless the UK withdrawal agreement establishes exceptions.

3. UK manufacturer cannot act as importer anymore
According to European Union product legislation, the importer is the economic operator established in the Union who places a product from a third country on the Union market. As from the withdrawal date, a manufacturer or importer established in the United Kingdom will no longer be considered as an economic operator established in the Union.

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Über uns

Firmenporträt

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.  

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Unternehmensdaten

Gründungsjahr

1990

Geschäftsfelder
  • Elektromedizin / Medizintechnik
  • Medizinische Dienstleistungen und Verlagserzeugnisse