• 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
    • 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
  • 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

COVID-19 Special

COVID-19, News in Brief

Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons

March 8, 2021
COVID-19, News in Brief

European Commission publishes Q&A guidance on COVID-19 tests

March 1, 2021
COVID-19

Defined performance criteria for rapid SARS-CoV-2 antigen tests

November 5, 2020

News In Brief

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Important Notice, IVDR, MDR, News in Brief

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

March 15, 2021
IVDR, MDR, News in Brief

Voluntary registration with EUDAMED database – industry fears duplicate registrations

January 23, 2021
Important Notice, MDR, News in Brief

mdi Europa experience on MDR technical documentation reviews

January 14, 2021
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
IVDR, News in Brief

EU IVD medical devices sector destined for crisis?

November 6, 2020
Important Notice, MDR, News in Brief

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020

News on Brexit

Additional MHRA guidance for medical device companies

January 17, 2021

Latest UK MHRA updates on Northern Ireland and EU device regulation guidance

October 26, 2020

New UKCA mark after Brexit

September 17, 2020

Brexit and the regulatory situation for the medtech industry

February 3, 2020

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

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

March 15, 2021

Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons

March 8, 2021

European Commission publishes Q&A guidance on COVID-19 tests

March 1, 2021

News In Brief

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
Important Notice, IVDR, MDR, News in Brief

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

The Medical Device Coordination Group (MDCG) has issued a new guidance document MDCG 2021-1, Guidance on harmonised administrative practices and alternative technical solutions until  EUDAMED is fully functional. The document… Read More

March 15, 2021
IVDR, MDR, News in Brief

Voluntary registration with EUDAMED database – industry fears duplicate registrations

The first module of the EU medical device database, EUDAMED, is up and running. However, because actor registration is voluntary until 26 May 2022, when the complete database is planned… Read More

January 23, 2021
Important Notice, MDR, News in Brief

mdi Europa experience on MDR technical documentation reviews

Under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), EU Authorized Representatives are – among others – in charge of… Read More

January 14, 2021
CE Marking, Download Section Service, Guidance Documents, IVDR Service, Legislation Documents, Library, MDR Service

Complete Download 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 more than 40 important… Read More

December 21, 2020
Important Notice

Key guidance document on the classification of IVDs under the IVDR

The European Commission has published a key guidance document on the classification of in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)… Read More

December 1, 2020
mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!
IVDR, News in Brief

EU IVD medical devices sector destined for crisis?

The European Commission has fallen behind when it comes to providing guidance and structures required to support the in vitro medical devices sector in timely compliance with Regulation (EU) 2017/746… Read More

November 6, 2020
Important Notice, MDR, News in Brief

Sufficient clinical evidence under the MDR for class I legacy devices

This article discusses the major aspects covered by the guidance document MDCG 2020-6, Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC, herein referred to… Read More

November 3, 2020
IVDR, MDR, News in Brief

New website on actor registration in EUDAMED 3 available

In August 2020, the Medical Device Coordination Group (MDCG) announced that the economic operator registration or actor registration module will be available as of December 1, 2020. This module will serve… Read More

October 29, 2020

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 Marking Certificates of Free Sale Certificates of Free Sales Checklists Clinical Evaluation COVID-19 Drug Device Combination EU Authorised Representative 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 PPE Regulatory Affairs Security Advice Templates UDI Unique Device Identification Vigilance WHO

What are you looking for?

  • Composition of scientific, medical and geographic motives to illustrate an MDR/IVDR compliance process topics

    Supportive Information Section mdi Europa

  • Complete Download Section mdi Europa

  • The Regulatory Affairs Network That Keeps Your Business Safe

  • Stop your Confusion about CE Marking – read our FAQ

  • Complete Link Section mdi Europa

  • Certificates of Free Sale

Legal terms

  • Imprint
  • Copyrights
  • Privacy Policy

Contact us

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

Office address

mdi Europa GmbH

Langenhagener Str. 71
D-30855 Langenhagen
Germany

Recently posted articles

mdi Europa EU Authorized Representative gets you ready for Performance Evaluation. Start Now!

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons

European Commission publishes Q&A guidance on COVID-19 tests

Browse website by categories

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

Search website

Search archive

  • March 2021 (3)
  • February 2021 (1)
  • January 2021 (3)
  • December 2020 (3)
  • November 2020 (3)
  • October 2020 (5)
  • September 2020 (3)
  • August 2020 (4)
  • July 2020 (3)
  • June 2020 (6)
  • May 2020 (2)
  • April 2020 (6)
  • March 2020 (4)
  • February 2020 (2)
  • January 2020 (2)
  • December 2019 (6)
  • November 2019 (2)
  • October 2019 (6)
  • September 2019 (6)
  • August 2019 (6)
  • 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)
  • © 2021 mdi Europa.
  • Privacy Policy
  • Powered by WordPress
  • Theme: Weta by Elmastudio.
Top