• Partners & Associates
    • General Network Information
    • Partners for European Services
    • Partners for International Approvals
  • FAQ
  • Contact / About Us
    • Contact Persons
    • Contact Details
    • About mdi Europa
    • Team mdi Europa
    • Reviews from Customers and Partners
  • info@mdi-europa.com

mdi Europa

Full Service EU Authorized Representative | CE Marking

  • Home
    • Meet mdi Europa
    • Hottest News and Brexit
    • “News in Brief” Preview
    • Important Notices and More
    • Learn from mdi Europa
  • CE Marking Medical Devices
    • CE Marking
    • CE Approval
    • New Regulations MDR/IVDR
      • MDR – Medical Devices Regulation (EU) 2017/745
      • IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
    • Certificates of Free Sale
    • AIMDD – Active Implantable Medical Devices Directive
    • MDD – Medical Devices Directive
    • IVDD – In Vitro Diagnostic Medical Devices Directive
    • OEM – Private Labeling
    • Technical File Compilation
    • Declaration of Conformity
    • CE Consulting Electrical Equipment
      • EMC – Electromagnetic Compatibility Directive
      • LVD – Low Voltage Directive
    • CE Consulting Environmental Requirements
      • WEEE – Waste Electrical and Electronic Equipment
      • RoHS – Restriction of Hazardous Substances
  • EU Authorized Representative
    • European Authorized Representation for Manufacturers of Medical Devices
    • EU Authorized Representative Responsibilities
    • EU Authorized Representative vs. Distributor
  • MDR
    • About the Medical Devices Regulation (EU) 2017/745
    • Major Aspects of the MDR
  • IVDR
    • About the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
    • Major Aspects of the IVDR
  • News ++
    • News Overview
    • News in Brief
  • Library
    • Library Information Overview
    • Complete Download Section
      • Download Section Legislation Documents
      • Download Section Guidance Documents MDR
      • Download Section Guidance Documents IVDR
    • Supportive Information Section MDR/IVDR
      • Supportive Information MDR
      • Supportive Information IVDR
    • Complete Link Section
    • FAQ Section
  • Partners & Associates
    • General Network Information
    • Partners for European Services
    • Partners for International Approvals
  • FAQ
  • Contact / About Us
    • Contact Persons
    • Contact Details
    • About mdi Europa
    • Team mdi Europa
    • Reviews from Customers and Partners
  • info@mdi-europa.com

  • Meet mdi Europa at Medica and Arab Health

  • Businessman in search for an European Authorized Representative

    Don’t Search No More, For Your EU Authorized Representative

  • All About Brexit – But We’re Not Clairvoyant

  • Softdrinks at the beach, instead of EU Regulations Horror

    CE Marking Made Easy, Like a Day at the Beach

Important Notice, News in Brief

News on EUDAMED

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Guidance Documents, Important Notice, IVDR

Performance Evaluation for IVD Medical Devices

CE Marking Service, EU Authorized Representative Service, Important Notice

Meet mdi Europa at Medica and Arab Health

Important Notice

MDCG Guidance on MDD Certificates and SSCP under the MDR

Important Notice, News in Brief

European Commission Website on Regulations MDR / IVDR Restructured

Important Notice, News in Brief

Guidance on Person Responsible for Regulatory Compliance

News on Brexit

News on Brexit

October 29, 2019

New Guidance for the UK Responsible Person Published

September 26, 2019

United Kingdom (UK) to Request ‘UK Responsible Person’

August 19, 2019

Details about the Regulation of Medical Devices in Case of No-Deal Brexit

February 28, 2019

News in Brief

News on EUDAMED

November 7, 2019

DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR

November 6, 2019

Guidance on Qualification and Classification of Software under the MDR and IVDR Published

October 28, 2019
Important Notice, News in Brief

News on EUDAMED

From different sources we have heard that the introduction of EUDAMED will be delayed – probably for two years. In the meantime, this has been confirmed on the European Commission’s… Read More

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Guidance Documents, Important Notice, IVDR

Performance Evaluation for IVD Medical Devices

Performance evaluations will take an integral part in the CE Marking process of in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). This article outlines,… Read More

CE Consulting

The Regulatory Affairs Network That Keeps Your Business Safe

mdi Europa specializes on the services of an EU Authorized Representative*, but we also provide a worldwide network of highly experienced consultants and experts on regulatory affairs. Translations, market research,… Read More

CE Marking Service, EU Authorized Representative Service, Important Notice

Meet mdi Europa at Medica and Arab Health

Meet mdi Europa at Medica mdi Europa will attend Medica from November 18 to 20, 2019. Please contact us if you wish to schedule a meeting. Contact team mdi Europa… Read More

Important Notice

MDCG Guidance on MDD Certificates and SSCP under the MDR

Manufacturers of medical devices are eagerly waiting for more guidance on the implementation of the MDR. MDCG has now issued a useful guidance on the Summary of Safety and Clinical… Read More

Important Notice, News in Brief

European Commission Website on Regulations MDR / IVDR Restructured

The European Commission has restructured and further developed its website on the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). We strongly… Read More

CE Consulting, CE Marking Service, EU Authorized Representative Service

A True Story about Trust and Guidance

If you raise a wonderful child – would you lay its destiny in the hands of someone who isn’t loyal? We wouldn’t! As a family owned business with a moving… Read More

CE Marking, EU Authorized Representative, IVDR Service, Library, Link Section Service, MDR Service

Complete Link Section mdi Europa

The section below is intended for all parties who are involved in the manufacturing of medical devices including in vitro diagnostic medical devices. You will find an up to date… Read More

In our Customers own Words

We are having your guidance more than expected.

S. Mittal · Mediplus (India) Ltd.

Browse articles by keyword

About mdi Europa AIMDD Assessment Routes BfArM Brexit Case Study CE Consulting CE Marking Certificates of Free Sale Certificates of Free Sales Checklists Clinical Evaluation Drug Device Combination EU Authorized Representative EUDAMED European Commission FAQ Guidance Documents Inside Informations IVDD IVDR IVDR News Legacy Devices MDCG MDD MDR MDR News Medical Devices News in Brief No-Deal Brexit Notified Body OEM OEM Private Labeling Performance Evaluation Regulatory Affairs Security Advice Templates UDI Unique Device Identification Vigilance WHO

What are you looking for?

  • The Regulatory Affairs Network That Keeps Your Business Safe

  • Stop your Confusion about CE Marking – read our FAQ

  • Complete Link Section mdi Europa

  • Complete Download Section mdi Europa

  • Supportive Information Section mdi Europa

  • Certificates of Free Sale

Legal terms

  • Imprint
  • Copyrights
  • Privacy Policy

Office address

mdi Europa GmbH

Langenhagener Str. 71
D-30855 Langenhagen
Germany

Contact us

  • info@mdi-europa.com
  • +49 511 39089530
  • Contact Persons
  • Contact Details
  • About us
  • Team mdi Europa
  • History of mdi Europa

Recently posted articles

News on EUDAMED

DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR

News on Brexit

Browse website by categories

  • Brexit
  • MDR
  • IVDR
  • CE Marking
  • EU Authorized Representative
  • FAQ
  • Library

Search website

Search archive

  • November 2019 (2)
  • October 2019 (7)
  • September 2019 (6)
  • August 2019 (8)
  • July 2019 (4)
  • June 2019 (8)
  • May 2019 (3)
  • April 2019 (4)
  • March 2019 (1)
  • February 2019 (2)
  • January 2019 (1)
  • December 2018 (4)
  • November 2018 (1)
  • October 2018 (1)
  • September 2018 (1)
  • © mdi Europa GmbH 2019
Top