EU Authorized Representative Services for Medical Devices

News Blog

8 Jul 2020

Notified Body GMED (France) is No.15 on the NANDO database to receive MDR designation.
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17 Apr 2020

The European Council and the European Parliament postponed the Date of Application (DoA) for 1 year for Medical Device Regulation (MDR) 2017/745 due to COVID-19 crisis. At this time just 13 Notified Bodies are designated under the MDR legislation.

  • 24 Jan 2020
    The draft standardisation request for MDR and IVDR was submitted to the Committee on Standards with the need to provide an adequate legal basis for the development of harmonised European standards and been issued to CEN and CENELEC, the European Standardisation Organisations.
    Annex I of this request lists the existing standards to be revised, and new standards to be drafted under the MDR while Annex II of this request lists the existing standards to be revised, and new standards to be drafted under IVDR
  • 20 Jan 2020
    Swiss Medtech recommends Swiss medical device manufacturers to fulfill requirements of a third country manufacturers at the 26 May 2020. This means especially to have an Authorized Representative in place. Read more
  • 11 Dec 2019
    Swiss Medtech recommends to manufacturers to prepare on worst case scenario regarding situation with Mutual Recognition Agreement.
    Have you already considered to work with service provider EUmediq as Authorized Representative? Read more
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EU Authorized Representative
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Consulting Services
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Audit Services ISO 19011
(ISO 13485 & MDSAP / ISO 9001)
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Education & Training
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About us

EUmediq GmbH is a group of high qualified experts with focus on medical device related topics. EUmediq offers services in EU Authorized Representation, Postmarket Surveillance, Training, Auditing and Interim Management.
Our Team

EUmediq has a Quality Management System according to ISO 13485:2016 and is intended to be certified in a couple of weeks for its services and therefore an outstanding service provider for medical device companies.
Our Partners

EUmediq GmbH
Mörfelder Landstrasse 6-8
60598 Frankfurt am Main

Place of Jurisdiction: Registry Court Frankfurt a. Main
Registry ID: HRB 119557

Phone: +41 79 476 43 19

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