medical device distributor pilot inspections - etouches · pdf filemedical device distributor...
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![Page 1: Medical Device Distributor pilot inspections - etouches · PDF fileMedical Device Distributor pilot inspections Wholesale Distribution Conference 8th February 2017 Darren Scully Health](https://reader031.vdocument.in/reader031/viewer/2022021818/5ab0e9427f8b9abc2f8c00f7/html5/thumbnails/1.jpg)
Medical Device Distributor
pilot inspections
Wholesale Distribution Conference
8th February 2017
Darren Scully
Health Products Distribution Manager
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Perspective
approach
pilot inspections individual feedback
guidance document wider findings
HPRA
approach
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Timeline
Feedback from pilot inspections
method
guidance
document
invitations
assessments
inspections
Q1 2017
August
2015
Q1
2016
October
2015
Target
small
medium
large
range of companies and products
![Page 4: Medical Device Distributor pilot inspections - etouches · PDF fileMedical Device Distributor pilot inspections Wholesale Distribution Conference 8th February 2017 Darren Scully Health](https://reader031.vdocument.in/reader031/viewer/2022021818/5ab0e9427f8b9abc2f8c00f7/html5/thumbnails/4.jpg)
Feedback from inspection programme
findings
Paragraph 1 - Act with due care
Paragraph 2 - Requirements
Paragraph 3 - Transport & Storage
Paragraph 4 - Non-conformity & Serious Risk
Paragraph 5 - Complaints, Non-conforming
Products, Recalls & Withdrawal
Paragraph 6 - Cooperation with Competent
Authority
Article 12 (subject to change)
* Article 21 of IVD Reg
Article 23* (subject to change)
Paragraph 1 - Cooperation with Manufacturer
or Authorised Representative
Paragraph 2 - Supply Chain Identity
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Feedback from inspection programme
paragraph 3 – transport & storage
- risk-based probe location
- handling of excursions
- calibration
issues
- temperature & RH
- validation
practical aspects
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Feedback from inspection programme
paragraph 2 - requirements
- CE mark presence
- conformity
- imported products
practical aspects
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Feedback from inspection programme
paragraph 2 - requirements
- declaration of conformity
- checks on conformity
- when not conforming?
issues
- CE mark presence
- conformity
- imported products
practical aspects
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Feedback from inspection programme
paragraph 2 - requirements
- CE mark presence
- conformity
- imported devices
practical aspects USA
RoI
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Feedback from inspection programme
paragraphs 2 & 4 - requirements
- lack of understanding
- not just a counterfeit
issues
- serious risk
- falsified devices
- complaints
practical aspects
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Feedback from inspection programme
paragraphs 2 & 4 - requirements
- register
- investigations
- trends
issues
- serious risk
- falsified devices
- complaints
practical aspects
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- identification of needs
- continuing training
- assessment
issues
- training
- technical agreements
practical aspects
Feedback from inspection programme
general guidance
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- transportation
- security
issues
- training
- technical agreements
practical aspects
Feedback from inspection programme
general guidance
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Feedback from inspection programme
general guidance
- deviation documentation
- implement change control
- management involvement
practical aspects
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documentation
Feedback from inspection programme
general guidance
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text questions to: 0873769292
Medical Device Distributor
pilot inspections