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UID:20260808T054044Z - 44298@odoo-6c455687b8-9vjd8
DTSTART;TZID=Europe/Stockholm:20261006T090000
DTEND;TZID=Europe/Stockholm:20261006T160000
CREATED:20260808T054044Z
DESCRIPTION:CE Marking of Medical Devices (MDR/IVDR) - The Big Picture - Day 1\nA
s a manufacturer\, importer\, or distributor of medical devices on the EU
market\, you operate in one of the world's most regulated landscapes. CE m
arking is not just a label – it is proof that your product meets strict
requirements for safety\, performance\, documentation\, and quality manage
ment. 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 recomme
nd 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 M
DR and IVDR: UDI labelling\, cybersecurity\, enhanced clinical evaluation\
, and more extensive technical documentation are just a few examples. We c
ut through the complexity – and help you see the full picture. The funda
mental purpose of the regulations is to protect patients and users. But th
e consequences of non-compliance are also very real: market bans\, product
recalls\, and liability claims. This course focuses on the path to CE mar
king. We explain\, discuss\, and practice key concepts – and walk throug
h how technical documentation should be structured and what role regulator
y authorities and Notified Bodies play. Programme Overview Day 1 – The B
ig PictureBackground – why CE marking?EU directives and regulations\, na
tional authorities and legislationOther applicable legislation\, including
the AI Act\, REACH\, RoHS\, the new Notified Body Regulation\, Battery Re
gulation\, and moreMDR and IVDR – an overviewProposed updates to MDR/IVD
RWhat's new in the regulations: UDI\, EUDAMED\, Person Responsible for Reg
ulatory Compliance\, and moreKey definitions and concepts: Intended Purpos
e\, Notified Body\, Risk Class\, Declaration of Conformity\, Harmonised St
andards\, MDCG guidance documents Course Objectives The aim is to give you
a solid [...]
DTSTAMP:20260808T054044Z
SUMMARY:CE Marking of Medical Devices (MDR/IVDR) - The Big Picture - Day 1
X-ALT-DESC;FMTTYPE=text/html:CE Marking of Medical Devices (MDR/IVDR) - The Big Pictu
re - Day 1\nAs a manufacturer\, importer\, or distributor of medical d
evices 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 prod
uct meets strict requirements for safety\, performance\, documentation\, a
nd quality management. This training provides a clear and practical walkth
rough of what it takes to CE mark your product and bring it to market. Thi
s 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. Cybersecur
ity and AI\, but it is not mandatory. The requirements have tightened sign
ificantly under MDR and IVDR: UDI labelling\, cybersecurity\, enhanced cli
nical evaluation\, and more extensive technical documentation are just a f
ew examples. We cut through the complexity – and help you see the full p
icture. The fundamental purpose of the regulations is to protect patients
and users. But the consequences of non-compliance are also very real: mark
et bans\, product recalls\, and liability claims. This course focuses on t
he 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. Programme Overv
iew Day 1 – The Big PictureBackground – why CE marking?EU directives a
nd regulations\, national authorities and legislationOther applicable legi
slation\, including the AI Act\, REACH\, RoHS\, the new Notified Body Regu
lation\, 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 concep
ts: Intended Purpose\, Notified Body\, Risk Class\, Declaration of Conform
ity\, Harmonised Standards\, MDCG guidance documents Course Objectives The
aim is to give you a solid [...]
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