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CE Marking Medical Devices
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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
Tag:
News in Brief
News in Brief
Availability swissdamed and new negotiations between the EU and Switzerland
April 5, 2024
News in Brief
EU notified bodies on harmonised standards regarding cybersecurity
January 6, 2023
Brexit
Extra year for CE-marked devices to access UK market
January 6, 2023
News in Brief
EU notified body technical documentation reviews
November 17, 2022
News in Brief
Cybersecurity in the EU
November 8, 2022
News in Brief
EU has to deal with discords between AI and medical device rules
July 1, 2022
Important Notice
Ukraine tries to maintain business as usual
April 6, 2022
News in Brief
New cybersecurity standard
April 2, 2022
Important Notice
Insufficient sterilization of medical devices by Steril Milano S.r.l
June 28, 2021
News in Brief
BfArM informs about damages to hip implants
December 13, 2020
Important Notice
Medical Device Distribution in France
May 18, 2020
Important Notice
,
News in Brief
News on EUDAMED
November 7, 2019
News in Brief
DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR
November 6, 2019
News in Brief
Guidance on Qualification and Classification of Software under the MDR and IVDR Published
October 28, 2019
Important Notice
,
News in Brief
European Commission Website on Regulations MDR / IVDR Restructured
August 21, 2019
News in Brief
New Checklist for Clinical Evaluations Available
August 19, 2019
News in Brief
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
August 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
Important Notice
,
News in Brief
Guidance on Person Responsible for Regulatory Compliance
June 23, 2019
News in Brief
Guidance on Implant Cards
June 23, 2019
Important Notice
,
News in Brief
Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics
June 14, 2019
News in Brief
BfArM Recommendation on Paclitaxel-coated Stents and Balloons
June 13, 2019
News in Brief
LRQA to Withdraw Notified Body Services
June 13, 2019
News in Brief
Quality Assurance Agreements (QAA)
June 11, 2019
News in Brief
EU Guidance on Quality Rules for Drug-Device Combinations
June 4, 2019
News in Brief
Spain’s Only Notified Body Not Accepting Applications for Certification of New Products
June 3, 2019
News in Brief
The World Health Organisation’s (WHO) New Draft Guideline
May 28, 2019
News in Brief
EU Authorities Might Review Products in Case of Notified Body (NB) Shortage
May 20, 2019
News in Brief
Swiss Medical Device Manufacturers Under Pressure
April 26, 2019
News in Brief
Draft Policy on Remaining Shelf-Life for Medical Products
April 17, 2019
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