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UID:20260831T074640Z - 15629@odoo-57766ccd69-mgjlj
DTSTART;TZID=Europe/Stockholm:20261006T090000
DTEND;TZID=Europe/Stockholm:20261006T160000
CREATED:20260831T074640Z
DESCRIPTION:<a href="https://ido.intertek.com/event/ce-marking-of-medical-d
 evices-mdr-ivdr-the-big-picture-day-1-114/register">CE Marking of Medical 
 Devices (MDR/IVDR) - The Big Picture - Day 1</a>\nAs a manufacturer\, impo
 rter\, or distributor of medical devices on the EU market\, you operate in
  one of the world's most regulated landscapes. CE marking is not just a la
 bel – it is proof that your product meets strict requirements for safety
 \, performance\, documentation\, and quality management. This training pro
 vides a clear and practical walkthrough of what it takes to CE mark your p
 roduct and bring it to market. This is part 1 (day 1) of the course CE Mar
 king of Medical Devices (MDR/IVDR). We also recommend to join Part 2 (day 
 2) is a deep dive incl. Cybersecurity and AI\, but it is not mandatory. Th
 e requirements have tightened significantly under MDR and IVDR: UDI labell
 ing\, cybersecurity\, enhanced clinical evaluation\, and more extensive te
 chnical documentation are just a few examples. We cut through the complexi
 ty – and help you see the full picture. The fundamental purpose of the r
 egulations is to protect patients and users. But the consequences of non-c
 ompliance are also very real: market bans\, product recalls\, and liabilit
 y claims. This course focuses on the path to CE marking. We explain\, disc
 uss\, and practice key concepts – and walk through how technical documen
 tation should be structured and what role regulatory authorities and Notif
 ied Bodies play. Program Overview Day 1 – The Big PictureBackground – 
 why CE marking?EU directives and regulations\, national authorities and le
 gislationOther applicable legislation\, including the AI Act\, REACH\, RoH
 S\, the new Notified Body Regulation\, Battery Regulation\, and moreMDR an
 d IVDR – an overviewProposed updates to MDR/IVDRWhat's new in the regula
 tions: UDI\, EUDAMED\, Person Responsible for Regulatory Compliance\, and 
 moreKey definitions and concepts: Intended Purpose\, Notified Body\, Risk 
 Class\, Declaration of Conformity\, Harmonised Standards\, MDCG guidance d
 ocuments Course Objectives The aim is to give you a solid and [...]
DTSTAMP:20260831T074640Z
SUMMARY:CE Marking of Medical Devices (MDR/IVDR) - The Big Picture - Day 1
X-ALT-DESC;FMTTYPE=text/html:<a href="https://ido.intertek.com/event/ce-mar
 king-of-medical-devices-mdr-ivdr-the-big-picture-day-1-114/register">CE Ma
 rking of Medical Devices (MDR/IVDR) - The Big Picture - Day 1</a>\nAs a ma
 nufacturer\, importer\, or distributor of medical devices on the EU market
 \, you operate in one of the world's most regulated landscapes. CE marking
  is not just a label – it is proof that your product meets strict requir
 ements for safety\, performance\, documentation\, and quality management. 
 This training provides a clear and practical walkthrough of what it takes 
 to CE mark your product and bring it to market. This is part 1 (day 1) of 
 the course CE Marking of Medical Devices (MDR/IVDR). We also recommend to 
 join Part 2 (day 2) is a deep dive incl. Cybersecurity and AI\, but it is 
 not mandatory. The requirements have tightened significantly under MDR and
  IVDR: UDI labelling\, cybersecurity\, enhanced clinical evaluation\, and 
 more extensive technical documentation are just a few examples. We cut thr
 ough the complexity – and help you see the full picture. The fundamental
  purpose of the regulations is to protect patients and users. But the cons
 equences of non-compliance are also very real: market bans\, product recal
 ls\, and liability claims. This course focuses on the path to CE marking. 
 We explain\, discuss\, and practice key concepts – and walk through how 
 technical documentation should be structured and what role regulatory auth
 orities and Notified Bodies play. Program Overview Day 1 – The Big Pictu
 reBackground – why CE marking?EU directives and regulations\, national a
 uthorities and legislationOther applicable legislation\, including the AI 
 Act\, REACH\, RoHS\, the new Notified Body Regulation\, Battery Regulation
 \, and moreMDR and IVDR – an overviewProposed updates to MDR/IVDRWhat's 
 new in the regulations: UDI\, EUDAMED\, Person Responsible for Regulatory 
 Compliance\, and moreKey definitions and concepts: Intended Purpose\, Noti
 fied Body\, Risk Class\, Declaration of Conformity\, Harmonised Standards\
 , MDCG guidance documents Course Objectives The aim is to give you a solid
  and [...]
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