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CE Marking Medical Devices
CE Marking
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MDR
IVDR
Certificates of Free Sale
OEM – Private Labeling
Technical File Compilation
Declaration of Conformity
CE Consulting Electrical Equipment – EMC / LVD
CE Consulting Environmental Requirements – WEEE / RoHS
EU Authorized Representative
European Authorized Representation for Manufacturers of Medical Devices
EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
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Home
CE Marking Medical Devices
CE Marking
CE Approval
MDR
IVDR
Certificates of Free Sale
OEM – Private Labeling
Technical File Compilation
Declaration of Conformity
CE Consulting Electrical Equipment – EMC / LVD
CE Consulting Environmental Requirements – WEEE / RoHS
EU Authorized Representative
European Authorized Representation for Manufacturers of Medical Devices
EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
Search results
News in Brief
Team-NB position papers on MDR and IVDR technical documentation
June 7, 2023
News in Brief
EU notified body technical documentation reviews
November 17, 2022
Important Notice
,
MDR
mdi Europa experience on MDR technical documentation reviews
January 14, 2021
News in Brief
Technical Documentation format under the MDR and IVDR
December 1, 2019
CE Marking
,
MDR
Technical Documentation Requirements under the MDR – a Case Study
January 14, 2019
Technical File Compilation
August 2, 2023
News in Brief
Manufacturers must act now to satisfy IVDR
December 4, 2023
FAQ Section mdi Europa
August 2, 2023
EU Authorized Representative vs. Distributor
August 2, 2023
IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
August 2, 2023
MDR – Medical Devices Regulation (EU) 2017/745
August 2, 2023
OEM – Private Labeling
August 2, 2023
Library
,
Supportive Information
Supportive Information Section mdi Europa
August 1, 2023
About mdi Europa
July 19, 2023
Partners & Associates
July 17, 2023
News in Brief
News on guidance documents
March 3, 2023
MDR
,
News in Brief
elFU rules under the EU‘s MDR
January 26, 2022
IVDR
,
MDR
,
News in Brief
MDCG guidance document on distributors and importers published
December 12, 2021
Important Notice
,
MDR
New European Commission guidance document on MDR medical device classification
October 11, 2021
COVID-19
,
News in Brief
The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
August 5, 2021
Important Notice
,
IVDR
IVD or not IVD? That is the question…
April 15, 2021
COVID-19
Defined performance criteria for rapid SARS-CoV-2 antigen tests
November 5, 2020
IVDR
,
MDR
,
News in Brief
Practical advice for setting up an MDR and IVDR compliant PMS Plan
October 22, 2020
MDR
,
News in Brief
ISO TR 20416 and PMS under the MDR
August 1, 2020
Important Notice
,
MDR
Clinical evaluation and equivalence – using literature under the MDR
June 5, 2020
Important Notice
,
IVDR
,
MDR
MDR and IVDR guidance updates
April 9, 2020
News in Brief
Latest version of ISO 14971 on risk management and the MDR and IVDR
January 8, 2020
Important Notice
MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published
January 6, 2020
Important Notice
Guidance document for class I device manufacturers
December 23, 2019
Important Notice
,
MDR
Second MDR corrigendum published
December 18, 2019
Brexit
New Guidance for the UK Responsible Person Published
September 26, 2019
News in Brief
New Checklist for Clinical Evaluations Available
August 19, 2019
Brexit
United Kingdom (UK) to Request ‘UK Responsible Person’
August 19, 2019
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