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Medical Device Distributor
pilot inspections
Wholesale Distribution Conference
8th February 2017
Darren Scully
Health Products Distribution Manager
Perspective
approach
pilot inspections individual feedback
guidance document wider findings
HPRA
approach
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
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
Feedback from inspection programme
paragraph 3 – transport & storage
- risk-based probe location
- handling of excursions
- calibration
issues
- temperature & RH
- validation
practical aspects
Feedback from inspection programme
paragraph 2 - requirements
- CE mark presence
- conformity
- imported products
practical aspects
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
Feedback from inspection programme
paragraph 2 - requirements
- CE mark presence
- conformity
- imported devices
practical aspects USA
RoI
Feedback from inspection programme
paragraphs 2 & 4 - requirements
- lack of understanding
- not just a counterfeit
issues
- serious risk
- falsified devices
- complaints
practical aspects
Feedback from inspection programme
paragraphs 2 & 4 - requirements
- register
- investigations
- trends
issues
- serious risk
- falsified devices
- complaints
practical aspects
- identification of needs
- continuing training
- assessment
issues
- training
- technical agreements
practical aspects
Feedback from inspection programme
general guidance
- transportation
- security
issues
- training
- technical agreements
practical aspects
Feedback from inspection programme
general guidance
Feedback from inspection programme
general guidance
- deviation documentation
- implement change control
- management involvement
practical aspects
documentation
Feedback from inspection programme
general guidance
text questions to: 0873769292
Medical Device Distributor
pilot inspections