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CE Marking Medical Devices
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IVDR
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OEM – Private Labeling
Technical File Compilation
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CE Consulting Electrical Equipment – EMC / LVD
CE Consulting Environmental Requirements – WEEE / RoHS
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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
Author:
Michael Sander
News in Brief
Guidance checklist for manufacturers of reusable and resterilizable medical devices
September 3, 2020
MDR
,
News in Brief
Commission to put forward another European standards request
August 24, 2020
IVDR
,
MDR
,
News in Brief
New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits
August 21, 2020
MDR
,
News in Brief
ISO TR 20416 and PMS under the MDR
August 1, 2020
Important Notice
EU guidance on Notified Body clinical evaluation assessment reports
July 24, 2020
MDR
,
News in Brief
European Commission’s device standardisation request rejected
June 23, 2020
Important Notice
,
MDR
Clinical evaluation and equivalence – using literature under the MDR
June 5, 2020
IVDR
,
MDR
,
News in Brief
New MDR and IVDR guidance documents published by MDCG and MedTech Europe
June 1, 2020
Important Notice
Medical Device Distribution in France
May 18, 2020
Important Notice
,
MDR
Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published
April 29, 2020
Important Notice
,
MDR
MDR Postponed by One Year!
April 28, 2020
Important Notice
,
MDR
MDR Postponement – Handle with Care!
April 21, 2020
Important Notice
,
IVDR
,
MDR
MDR and IVDR guidance updates
April 9, 2020
Important Notice
,
MDR
Latest MDCG Preparedness Plan and MDR Delay
March 26, 2020
News in Brief
Usability and the MDR
March 12, 2020
News in Brief
Update on Notified Bodies
March 4, 2020
Important Notice
New guidance documents for EMDN and cybersecurity
February 13, 2020
News in Brief
Latest version of ISO 14971 on risk management and the MDR and IVDR
January 8, 2020
Important Notice
Guidance document for class I device manufacturers
December 23, 2019
News in Brief
Technical Documentation format under the MDR and IVDR
December 1, 2019
News in Brief
DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR
November 6, 2019
Important Notice
,
IVDR
Performance Evaluation for IVD Medical Devices
October 28, 2019
News in Brief
New Notified Bodies Designated under the MDR and IVDR
October 15, 2019
News in Brief
BfArM Informs about Insufficient Labeling of Speaking Valves
July 31, 2019
News in Brief
Recommendation of BfArM regarding Breathing Hoses in Anesthesia
July 22, 2019
News in Brief
Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)
July 17, 2019
News in Brief
Most Important Changes – Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
July 16, 2019
News in Brief
BfArM Recommendation on Paclitaxel-coated Stents and Balloons
June 13, 2019
News in Brief
Spain’s Only Notified Body Not Accepting Applications for Certification of New Products
June 3, 2019
News in Brief
European Commission Confident that the MDR and the IVDR are on Track
May 30, 2019
News in Brief
EU Authorities Might Review Products in Case of Notified Body (NB) Shortage
May 20, 2019
CE Marking
,
MDR
Technical Documentation Requirements under the MDR – a Case Study
January 14, 2019
CE Consulting
,
IVDR
,
MDR
Notified Body Selection and Change
December 15, 2018
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