Partners & Associates
FAQ
Contact / About Us
info@mdi-europa.com

Full Service EU Authorized Representative | CE Marking

Home
CE Marking Medical Devices
EU Authorized Representative
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

Partners & Associates
FAQ
Contact / About Us
info@mdi-europa.com

Category: MDR

Technical Documentation Requirements under the MDR – a Case Study

January 14, 2019

by Michael Sander

You may already have asked yourself how Regulation (EU) 2017/745 on medical devices (MDR) affects the Technical Documentation requirements for your products. This is a very complex question and cannot be… Read More

Filed under CE Marking, MDR

Tagged Case Study, MDR

Notified Body Selection and Change

December 15, 2018

by Michael Sander

Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More

Filed under CE Consulting, IVDR, MDR

Tagged AIMDD, IVDD, IVDR, MDD, MDR, Notified Body

Important facts about mdi Europa

mdi Europa was founded in 2000 to provide high quality regulatory affairs services for medical devices and in vitro diagnostics worldwide.
Our customers are:

manufacturers
importers
exporters
distributors

Our high quality compliance solutions, as confirmed by our ISO 9001:2015 certification include:

classification
identification of EU standards
Technical Documentation compilation and review
product registration to national EU authorities
labeling compliance
Free Sales Certificates
market research
translation services and more

What are you looking for?

News ++

Your Personal Contact

Wether you already have special concerns or just need help in general, you might want to get in touch with the right person at mdi Europa.

Find out everything you need to know about us here.

How can we help you?

You might search our FAQ section
write an email info@mdi-europa.com
or give us a call on +49 511 39089530

In our Customers own Words

The level of service at mdi Europa is impeccable! Any time I email, I receive an instant response.
U.S. Client

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

Browse website by categories

Brexit
MDR
IVDR
CE Marking
EU Authorized Representative
FAQ
Library

Search website

Search archive

October 2019 (4)
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)

Top

Category: MDR

Technical Documentation Requirements under the MDR – a Case Study

Notified Body Selection and Change

The Regulatory Affairs Network That Keeps Your Business Safe

Meet mdi Europa at Medica and Arab Health

MDCG Guidance on MDD Certificates and SSCP under the MDR