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
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
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
Important Notice
,
IVDR
Extended IVDR transition period for certain IVD medical devices
October 25, 2021
IVDR
,
MDR
,
News in Brief
,
Partners
Free intended use generator – an important tool under the MDR and IVDR
October 15, 2021
Important Notice
,
MDR
New European Commission guidance document on MDR medical device classification
October 11, 2021
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
Important Notice
Insufficient sterilization of medical devices by Steril Milano S.r.l
June 28, 2021
IVDR
,
MDR
,
News in Brief
Standard ISO 20417:2021 for the MDR and IVDR published
June 3, 2021
IVDR
,
MDR
,
News in Brief
EU clearance for MDR and IVDR harmonised standards
May 28, 2021
Important Notice
,
IVDR
IVD or not IVD? That is the question…
April 15, 2021
Important Notice
,
MDR
mdi Europa experience on MDR technical documentation reviews
January 14, 2021
News in Brief
BfArM informs about damages to hip implants
December 13, 2020
Important Notice
Key guidance document on the classification of IVDs under the IVDR
December 1, 2020
IVDR
,
News in Brief
EU IVD medical devices sector destined for crisis?
November 6, 2020
Important Notice
,
MDR
Sufficient clinical evidence under the MDR for class I legacy devices
November 3, 2020
IVDR
,
MDR
,
News in Brief
Practical advice for setting up an MDR and IVDR compliant PMS Plan
October 22, 2020
Previous Page
1
2
3
4
Next Page