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CE Marking Medical Devices
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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
MDCG published guidance on EMDN code updates and clinical investigation plans
March 13, 2024
News in Brief
MDCG published device specific vigilance guidance
February 8, 2024
Brexit
,
News in Brief
UK updated guidance will reflect EU extensions
May 15, 2023
News in Brief
News on guidance documents
March 3, 2023
Important Notice
EU guidance on Periodic Safety Update Reports
February 27, 2023
News in Brief
Guidance document on in-house devices
February 15, 2023
IVDR
,
MDR
,
News in Brief
EU guidance on authorised representatives
January 11, 2023
Important Notice
,
IVDR
,
MDR
New MDCG guidance documents under the MDR and IVDR
June 7, 2022
Important Notice
,
MDR
New guidance on borderline products between drugs and medical devices under the MDR
June 1, 2022
Important Notice
,
IVDR
MDCG publishes guidance on significant changes for legacy products under the IVDR
May 11, 2022
IVDR
,
News in Brief
New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices
March 4, 2022
COVID-19
,
News in Brief
New guidance for third-country manufacturers of COVID-19 IVD tests
February 6, 2022
IVDR
,
MDR
,
News in Brief
MDCG guidance document on distributors and importers published
December 12, 2021
MDR
,
News in Brief
New guidance on legacy devices published
November 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
IVDR
,
MDR
,
News in Brief
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
July 4, 2021
IVDR
,
MDR
,
News in Brief
Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN
June 15, 2021
COVID-19
,
News in Brief
Guidance document on the impact of genetic variants on SARS-COV-2
May 29, 2021
IVDR
,
MDR
,
News in Brief
Guidance on legacy devices regarding Eudamed
May 3, 2021
Important Notice
,
IVDR
,
MDR
New guidance documents published by the European Commission
May 2, 2021
Important Notice
,
IVDR
,
MDR
MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality
March 15, 2021
COVID-19
,
News in Brief
European Commission publishes Q&A guidance on COVID-19 tests
March 1, 2021
Brexit
,
News in Brief
Additional MHRA guidance for medical device companies
January 17, 2021
Important Notice
Key guidance document on the classification of IVDs under the IVDR
December 1, 2020
Brexit
,
News in Brief
Latest UK MHRA updates on Northern Ireland and EU device regulation guidance
October 26, 2020
News in Brief
Guidance checklist for manufacturers of reusable and resterilizable medical devices
September 3, 2020
IVDR
,
MDR
,
News in Brief
New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits
August 21, 2020
Important Notice
EU guidance on Notified Body clinical evaluation assessment reports
July 24, 2020
COVID-19
,
News in Brief
European Commission guidance on surgical masks
June 29, 2020
IVDR
,
MDR
,
News in Brief
New MDR and IVDR guidance documents published by MDCG and MedTech Europe
June 1, 2020
Important Notice
,
MDR
Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published
April 29, 2020
Important Notice
,
IVDR
,
MDR
MDR and IVDR guidance updates
April 9, 2020
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