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CE Marking Medical Devices
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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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UK Responsible Person (UKRP)
Swiss Authorized Representative
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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
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
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
Cybersecurity expertise shortage in EU
August 7, 2023
News in Brief
Team-NB position papers on MDR and IVDR technical documentation
June 7, 2023
News in Brief
MDCG 2020-3 updated
June 5, 2023
News in Brief
Proposed general product safety regulation is expected to entry into force shortly
May 2, 2023
Important Notice
Q&A document published on the extended transition period for medical devices under the MDR
April 11, 2023
Important Notice
MDR extended transition timelines and removal of MDR and IVDR sell-off period adopted
March 20, 2023
Important Notice
European Commission proposal text accepted
March 1, 2023
Important Notice
EU guidance on Periodic Safety Update Reports
February 27, 2023
News in Brief
Templates on hand for sponsors of IVD performance studies
February 15, 2023
News in Brief
New EU approach on cancer screening
February 15, 2023
News in Brief
Guidance document on in-house devices
February 15, 2023
Important Notice
European Commission proposal for extended transition timelines published
January 12, 2023
IVDR
,
MDR
,
News in Brief
EU guidance on authorised representatives
January 11, 2023
Important Notice
European Commission proposed MDR deadlines extension for legacy devices
December 14, 2022
News in Brief
EU notified body technical documentation reviews
November 17, 2022
News in Brief
News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations
October 13, 2022
News in Brief
Criticism on the EU’s 19-Point Regulatory Action Plan
October 11, 2022
Important Notice
Danger of cybersecurity attacks?
September 26, 2022
Important Notice
EU’s Implementing Regulation on Common Specifications for class D IVDs
September 6, 2022
News in Brief
EU has to deal with discords between AI and medical device rules
July 1, 2022
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
Important Notice
Ukraine tries to maintain business as usual
April 6, 2022
IVDR
,
News in Brief
EN ISO 13485 and symbols standards harmonised under the EU’s IVDR
February 27, 2022
MDR
,
News in Brief
MDR harmonised standards update
February 27, 2022
Important Notice
,
IVDR
IVDR clinical evidence
February 3, 2022
MDR
,
News in Brief
elFU rules under the EU‘s MDR
January 26, 2022
Important Notice
,
IVDR
European Commission proposal for progressive roll-out of the IVDR adopted
January 5, 2022
News in Brief
New artificial intelligence regulations could lead to unnecessary burdens
December 29, 2021
MDR
,
News in Brief
bsi white paper on clinical evaluations
December 15, 2021
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
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