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BEGIN:VEVENT
UID:20261028T213031Z - 53087@odoo-54dc9f858c-c7xvh
DTSTART;TZID=Europe/Stockholm:20261006T090000
DTEND;TZID=Europe/Stockholm:20261006T160000
CREATED:20261028T213031Z
DESCRIPTION:<a href="https://package-1.intertek.test.cloudworkz.eu/event/ce
 -marking-of-medical-devices-mdr-ivdr-the-big-picture-day-1-114/register">C
 E Marking of Medical Devices (MDR/IVDR) - The Big Picture - Day 1</a>\nAs 
 a manufacturer\, importer\, or distributor of medical devices on the EU ma
 rket\, you operate in one of the world's most regulated landscapes. CE mar
 king is not just a label – it is proof that your product meets strict re
 quirements for safety\, performance\, documentation\, and quality manageme
 nt. This training provides a clear and practical walkthrough of what it ta
 kes 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
  through the complexity – and help you see the full picture. The fundame
 ntal purpose of the regulations is to protect patients and users. But the 
 consequences of non-compliance are also very real: market bans\, product r
 ecalls\, and liability claims. This course focuses on the path to CE marki
 ng. We explain\, discuss\, and practice key concepts – and walk through 
 how technical documentation should be structured and what role regulatory 
 authorities and Notified Bodies play. Program Overview Day 1 – The Big P
 ictureBackground – why CE marking?EU directives and regulations\, nation
 al authorities and legislationOther applicable legislation\, including the
  AI Act\, REACH\, RoHS\, the new Notified Body Regulation\, Battery Regula
 tion\, and moreMDR and IVDR – an overviewProposed updates to MDR/IVDRWha
 t's new in the regulations: UDI\, EUDAMED\, Person Responsible for Regulat
 ory Compliance\, and moreKey definitions and concepts: Intended Purpose\, 
 Notified Body\, Risk Class\, Declaration of Conformity\, Harmonised Standa
 rds\, MDCG guidance documents Course Objectives The aim is to give you a s
 olid and [...]
DTSTAMP:20261028T213031Z
SUMMARY:CE Marking of Medical Devices (MDR/IVDR) - The Big Picture - Day 1
X-ALT-DESC;FMTTYPE=text/html:<a href="https://package-1.intertek.test.cloud
 workz.eu/event/ce-marking-of-medical-devices-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\, importer\, or distributor of medical dev
 ices on the EU market\, you operate in one of the world's most regulated l
 andscapes. CE marking is not just a label – it is proof that your produc
 t meets strict requirements for safety\, performance\, documentation\, and
  quality management. This training provides a clear and practical walkthro
 ugh 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. Cybersecurit
 y and AI\, but it is not mandatory. The requirements have tightened signif
 icantly under MDR and IVDR: UDI labelling\, cybersecurity\, enhanced clini
 cal evaluation\, and more extensive technical documentation are just a few
  examples. We cut through the complexity – and help you see the full pic
 ture. The fundamental purpose of the regulations is to protect patients an
 d users. But the consequences of non-compliance are also very real: market
  bans\, product recalls\, 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 authorities and Notified Bodies play. Program Overview Da
 y 1 – The Big PictureBackground – why CE marking?EU directives and reg
 ulations\, national authorities and legislationOther applicable legislatio
 n\, including the AI Act\, REACH\, RoHS\, the new Notified Body Regulation
 \, Battery Regulation\, and moreMDR and IVDR – an overviewProposed updat
 es to MDR/IVDRWhat's new in the regulations: UDI\, EUDAMED\, Person Respon
 sible for Regulatory Compliance\, and moreKey definitions and concepts: In
 tended Purpose\, Notified Body\, Risk Class\, Declaration of Conformity\, 
 Harmonised Standards\, MDCG guidance documents Course Objectives The aim i
 s to give you a solid and [...]
END:VEVENT
END:VCALENDAR