This live streaming video explains what a medical device CE Mark is and how to apply for CE Certification. The video includes an explanation of the difference between a CE with a Notified Body number and a CE without a Notified Body number. The video also explains the certification process, the relationship to ISO 13485:2016 certification, the labeling requirements, Economic Operators, and technical documentation.
In the discussion of technical documentation we cover: 1) Annex I - General Safety and Performance Requirements (GSPRs), 2) Annex II - Technical File Format and Contents, 3) Annex III - Post-Market Surveillance Requirements, and 4) Annex IV - Declaration of Conformity. The video also briefly discusses the requirements for Clinical Evaluation Reports.
Timestamps
0:00 Introduction
1:36 Changes to CE Certification Process
2:44 Regulation Classification
5:35 Economic Operators
7:51 Eudamed
9:22 Labeling with CE Symbol
11:00 Certification Process
12:41 Class I - Self Declaration
13:40 CE Requiring Notified Bodies
16:37 Technical Documentation
19:08 Annex I - GSPRs
20:47 Annex II - Format and Content of Technical File
21:06 Annex III - Post-Market Surveillance Documentation
21:42 Annex IV - Declaration of Conformity
21:55 Clinical Evaluation Report (CER)
23:19 Risk Management File
23:33 Comparison with Regulatory Process in Other Countries
23:55 Timeline for CE Marking
24:34 Recap
25:09 CE Marking is the most rigorous approval process in the world
25:46 PiP Scandal
26:15 Metal-on-Metal (MoM) Implant Recalls
27:20 Plan and Prepare for CE Marking
28:15 Thank you
Link to Regulations:
MDR -
IVDR -
If you want to learn more about CE Marking, here are some links to additional resources on our website:
Course -
Technical File Auditing Webinar -
CER Procedure & Webinar -
Risk Management File Training -
PMS Training -
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What Is A CE Mark And How To You Apply For Certification? For Country: United States. City: Aurora, Concord, Madison, Stamford, Wichita
