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BEGIN:VEVENT
UID:20260831T074434Z - 89591@odoo-57766ccd69-mgjlj
DTSTART;TZID=Europe/Stockholm:20261013T090000
DTEND;TZID=Europe/Stockholm:20261013T160000
CREATED:20260831T074434Z
DESCRIPTION:<a href="https://ido.intertek.com/event/ce-marking-of-medical-d
 evices-mdr-ivdr-deep-dive-day-2-117/register">CE Marking of Medical Device
 s (MDR/IVDR) - Deep Dive - Day 2</a>\nAs a manufacturer\, importer\, or di
 stributor 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 i
 s proof that your product meets strict requirements for safety\, performan
 ce\, documentation\, and quality management. This training provides a clea
 r and practical walkthrough of what it takes to CE mark your product and b
 ring it to market. This is part 1 (day 1) of the course CE Marking of Medi
 cal 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 requiremen
 ts have tightened significantly under MDR and IVDR: UDI labelling\, cybers
 ecurity\, enhanced clinical evaluation\, and more extensive technical docu
 mentation are just a few examples. We cut through the complexity – and h
 elp you see the full picture. The fundamental purpose of the regulations i
 s to protect patients and users. But the consequences of non-compliance ar
 e also very real: market bans\, product recalls\, and liability claims. Th
 is course focuses on the path to CE marking. We explain\, discuss\, and pr
 actice key concepts – and walk through how technical documentation shoul
 d be structured and what role regulatory authorities and Notified Bodies p
 lay. Program Overview Day 1 – The Big PictureBackground – why CE marki
 ng?EU directives and regulations\, national authorities and legislationOth
 er applicable legislation\, including the AI Act\, REACH\, RoHS\, the new 
 Notified Body Regulation\, Battery Regulation\, and moreMDR and IVDR – a
 n overviewProposed updates to MDR/IVDRWhat's new in the regulations: UDI\,
  EUDAMED\, Person Responsible for Regulatory Compliance\, and moreKey defi
 nitions and concepts: Intended Purpose\, Notified Body\, Risk Class\, Decl
 aration of Conformity\, Harmonised Standards\, MDCG guidance documents Cou
 rse Objectives The aim is to give you a solid and [...]
DTSTAMP:20260831T074434Z
SUMMARY:CE Marking of Medical Devices (MDR/IVDR) - Deep Dive - Day 2
X-ALT-DESC;FMTTYPE=text/html:<a href="https://ido.intertek.com/event/ce-mar
 king-of-medical-devices-mdr-ivdr-deep-dive-day-2-117/register">CE Marking 
 of Medical Devices (MDR/IVDR) - Deep Dive - Day 2</a>\nAs a manufacturer\,
  importer\, or distributor of medical devices on the EU market\, you opera
 te in one of the world's most regulated landscapes. CE marking is not just
  a label – it is proof that your product meets strict requirements for s
 afety\, performance\, documentation\, and quality management. This trainin
 g provides a clear and practical walkthrough of what it takes to CE mark y
 our product and bring it to market. This is part 1 (day 1) of the course C
 E 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 mandator
 y. The requirements have tightened significantly under MDR and IVDR: UDI l
 abelling\, cybersecurity\, enhanced clinical evaluation\, and more extensi
 ve technical documentation are just a few examples. We cut through the com
 plexity – and help you see the full picture. The fundamental purpose of 
 the regulations is to protect patients and users. But the consequences of 
 non-compliance are also very real: market bans\, product recalls\, and lia
 bility claims. This course focuses on the path to CE marking. We explain\,
  discuss\, and practice key concepts – and walk through how technical do
 cumentation should be structured and what role regulatory authorities and 
 Notified Bodies play. Program Overview Day 1 – The Big PictureBackground
  – why CE marking?EU directives and regulations\, national authorities a
 nd legislationOther applicable legislation\, including the AI Act\, REACH\
 , RoHS\, the new Notified Body Regulation\, Battery Regulation\, and moreM
 DR and IVDR – an overviewProposed updates to MDR/IVDRWhat's new in the r
 egulations: UDI\, EUDAMED\, Person Responsible for Regulatory Compliance\,
  and moreKey definitions and concepts: Intended Purpose\, Notified Body\, 
 Risk Class\, Declaration of Conformity\, Harmonised Standards\, MDCG guida
 nce documents Course Objectives The aim is to give you a solid and [...]
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