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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

events@hpra.ie

darren.scully@hpra.ie

compliance@hpra.ie

text questions to: 0873769292

Medical Device Distributor

pilot inspections