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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
MDR
,
News in Brief
bsi article on clinical evaluation requirements under the MDR
August 8, 2021
MDR
,
News in Brief
Team-NB publishes position paper on the applicability of MDR implant card requirements
August 1, 2021
News in Brief
bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning
July 12, 2021
News in Brief
The IVDR and performance evaluation studies
July 8, 2021
IVDR
,
MDR
,
News in Brief
EU UDI helpdesk available
June 10, 2021
Important Notice
,
IVDR
IVD or not IVD? That is the question…
April 15, 2021
Important Notice
,
IVDR
,
MDR
Updated EUDAMED implementation dates
April 1, 2021
COVID-19
,
News in Brief
Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons
March 8, 2021
IVDR
,
News in Brief
EU IVD medical devices sector destined for crisis?
November 6, 2020
COVID-19
Defined performance criteria for rapid SARS-CoV-2 antigen tests
November 5, 2020
Important Notice
,
MDR
Sufficient clinical evidence under the MDR for class I legacy devices
November 3, 2020
IVDR
,
MDR
,
News in Brief
New website on actor registration in EUDAMED 3 available
October 29, 2020
IVDR
,
MDR
,
News in Brief
Practical advice for setting up an MDR and IVDR compliant PMS Plan
October 22, 2020
IVDR
,
MDR
,
News in Brief
Get ready for the economic operator registration in EUDAMED
October 9, 2020
Brexit
,
News in Brief
New UKCA mark after Brexit
September 17, 2020
IVDR
,
MDR
,
News in Brief
EUDAMED economic operator registration module available as of December 2020
September 16, 2020
MDR
,
News in Brief
Commission to put forward another European standards request
August 24, 2020
MDR
,
News in Brief
ISO TR 20416 and PMS under the MDR
August 1, 2020
COVID-19
,
News in Brief
Update from the European Commission for protective equipment in the COVID-19 crisis
July 20, 2020
COVID-19
,
News in Brief
COVID-19 In Vitro Diagnostic Devices and Test Methods Database available
July 2, 2020
Important Notice
,
MDR
Clinical evaluation and equivalence – using literature under the MDR
June 5, 2020
COVID-19
,
Important Notice
,
News in Brief
Surgical and FFP masks in the COVID-19 crisis
May 8, 2020
Important Notice
,
MDR
MDR Postponement – Handle with Care!
April 21, 2020
Important Notice
,
News in Brief
European Commission Recommendation on Regulatory Exemptions for COVID-19 Products
March 23, 2020
Brexit
,
News in Brief
Brexit and the regulatory situation for the medtech industry
February 3, 2020
News in Brief
Latest version of ISO 14971 on risk management and the MDR and IVDR
January 8, 2020
News in Brief
Early access to Single Registration Numbers (SRN)
December 16, 2019
Important Notice
,
News in Brief
News on EUDAMED
November 7, 2019
Brexit
News on Brexit
October 29, 2019
Important Notice
,
IVDR
Performance Evaluation for IVD Medical Devices
October 28, 2019
Brexit
All About Brexit – But We’re Not Clairvoyant
September 16, 2019
News in Brief
News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices
September 4, 2019
Brexit
United Kingdom (UK) to Request ‘UK Responsible Person’
August 19, 2019
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