Don’t Have a Coronary... make the EU Regulatory Process work for you! (Cardiovascular Devices)

Описание: Filmed on October 9, 2024 - As the EU Medical Device Regulation (MDR) has raised the level of scrutiny required to place a device on the EU market, startup cardiovascular device manufacturers will need to have a better understanding on how to make the EU Regulatory process work for them to achieve a timely market access.

0:00 Introduction
2:43 The main players
5:44 CE Marking
10:12 Definition of the medical device - MDR Article 2.1
11:26 Classification - Annex VIII
13:02 Classification criteria
15:03 Classification rules
16:31 Conformity assessment: Article 2.40
24:45 General Safety and Performance Requirements (GSPRs)
29:56 Technical documentation requirements
33:05 Product codes: MDCG 2019-14
35:54 Risk management
38:18 Clinical evaluation
41:54 Post market surveillance: Article 2.60
45:20 Annex III Technical Documentation on Post-Market Surveillance
46:15 Post-market clinical follow up: Annex XIV (B)
47:56 Article 85 and 86 Post-market surveillance reports
49:17 PSUR vs SSCP overview
52:33 Applicable key guidance documents
52:49 Typical EU certification journey
56:48 Conclusion
57:41 Q&A

Speakers
Ibim Tariah - Technical Business Development Director – Medical Devices, SGS
Greg Jacobson - Sales Director - Medical Devices, SGS

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