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BEGIN:VEVENT
UID:20261028T212647Z - 29048@odoo-54dc9f858c-c7xvh
DTSTART;TZID=Europe/Stockholm:20261013T090000
DTEND;TZID=Europe/Stockholm:20261013T160000
CREATED:20261028T212647Z
DESCRIPTION:<a href="https://package-1.intertek.test.cloudworkz.eu/event/ce
 -marking-of-medical-devices-mdr-ivdr-deep-dive-day-2-117/register">CE Mark
 ing of Medical Devices (MDR/IVDR) - Deep Dive - Day 2</a>\nAs a manufactur
 er\, importer\, or distributor of medical devices on the EU market\, you o
 perate 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 f
 or safety\, performance\, documentation\, and quality management. This tra
 ining provides a clear and practical walkthrough of what it takes to CE ma
 rk your product and bring it to market. This is part 1 (day 1) of the cour
 se CE Marking of Medical Devices (MDR/IVDR). We also recommend to join Par
 t 2 (day 2) is a deep dive incl. Cybersecurity and AI\, but it is not mand
 atory. The requirements have tightened significantly under MDR and IVDR: U
 DI labelling\, cybersecurity\, enhanced clinical evaluation\, and more ext
 ensive technical documentation are just a few examples. We cut through the
  complexity – 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
  liability claims. This course focuses on the path to CE marking. We expla
 in\, discuss\, and practice key concepts – and walk through how technica
 l documentation should be structured and what role regulatory authorities 
 and Notified Bodies play. Program Overview Day 1 – The Big PictureBackgr
 ound – why CE marking?EU directives and regulations\, national authoriti
 es and legislationOther applicable legislation\, including the AI Act\, RE
 ACH\, RoHS\, the new Notified Body Regulation\, Battery Regulation\, and m
 oreMDR and IVDR – an overviewProposed updates to MDR/IVDRWhat's new in t
 he regulations: UDI\, EUDAMED\, Person Responsible for Regulatory Complian
 ce\, and moreKey definitions and concepts: Intended Purpose\, Notified Bod
 y\, Risk Class\, Declaration of Conformity\, Harmonised Standards\, MDCG g
 uidance documents Course Objectives The aim is to give you a solid and [..
 .]
DTSTAMP:20261028T212647Z
SUMMARY:CE Marking of Medical Devices (MDR/IVDR) - Deep Dive - Day 2
X-ALT-DESC;FMTTYPE=text/html:<a href="https://package-1.intertek.test.cloud
 workz.eu/event/ce-marking-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 operate in one of the world's most regulated landscapes. C
 E marking is not just a label – it is proof that your product meets stri
 ct requirements for safety\, performance\, documentation\, and quality man
 agement. 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 (d
 ay 1) of the course CE Marking of Medical Devices (MDR/IVDR). We also reco
 mmend to join Part 2 (day 2) is a deep dive incl. Cybersecurity and AI\, b
 ut it is not mandatory. The requirements have tightened significantly unde
 r MDR and IVDR: UDI labelling\, cybersecurity\, enhanced clinical evaluati
 on\, and more extensive technical documentation are just a few examples. W
 e cut through the complexity – and help you see the full picture. The fu
 ndamental purpose of the regulations is to protect patients and users. But
  the consequences of non-compliance are also very real: market bans\, prod
 uct recalls\, and liability claims. This course focuses on the path to CE 
 marking. We explain\, discuss\, and practice key concepts – and walk thr
 ough how technical documentation should be structured and what role regula
 tory authorities and Notified Bodies play. Program Overview Day 1 – The 
 Big PictureBackground – why CE marking?EU directives and regulations\, n
 ational authorities and legislationOther applicable legislation\, includin
 g the AI Act\, REACH\, RoHS\, the new Notified Body Regulation\, Battery R
 egulation\, and moreMDR and IVDR – an overviewProposed updates to MDR/IV
 DRWhat's new in the regulations: UDI\, EUDAMED\, Person Responsible for Re
 gulatory Compliance\, and moreKey definitions and concepts: Intended Purpo
 se\, Notified Body\, Risk Class\, Declaration of Conformity\, Harmonised S
 tandards\, MDCG guidance documents Course Objectives The aim is to give yo
 u a solid and [...]
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