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15/09/2014
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Case 1: CE Marking
15/09/2014
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CE Marking Process – Medical Devices
Sign
Select Notified Declaration
Medical
Conformity Body Of
Device?
Assessment Conformity Conformity,
Classification?
Route Assessment and Affix “CE
Mark”
Technical
QMS
Documentation
93/42/EEC (MDD)
ISO 13485
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90/385/EEC (AIMD) 6
CE Marking: Similar Requirements (MDD vs AIMD)
90/385/EEC
93/42/EEC
(Active
(Medical Device
Implantable
Directive)
Device Directive)
Design or Type
Class III Notified Body
Examination
September 2012
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Key Guidance Documents
• NB-Med 2.5.1 Technical Documentation (2000)
• NB Guidance Document
Audience Participation
• Performance testing?
If not, then why not?
• Design verification
data vs. clinical data Post production (yrs)
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Clinical Evaluation
Post Market Surveillance (PMS, PMCF, Complaints &
Incidents)
Risk
Labelling and IFU
Appropriate use of
Check label against Check IFU against
symbols – use of ISO
ER13.3 ER13.6
980/15223
For Reference