Procedure: Medical Device Recall
Country: Global Procedure
Version #: 01/17/2024
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

                                                                 

ID: GP-MD-DRC-SR
Category: Medical Devices
Validity: Change, withdrawn, or NRA update
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.

SUMMARY

Medical device recalls are usually self-initiated by the Market Authorization Holder (MAH) or on the National Regulatory Authority (NRA or NCA) request when NRA or MAH identifies the inconsistency issue, develops a recall plan, and conducts the recall engaging other parties (e.g., distributors) if necessary. The NRA is entitled to initiate a mandatory recall order to ensure the safety of patients to MAH and distributors, or MAH is initiating voluntary recall if non-compliance is detected. The entity initiating the recall shall duly submit the appropriate report to the NRA no later than 10 days from the moment the recall has been initiated in most countries. Should a correction or removal not be connected with a health risk or so-called Class III Recall it would be sufficient for a party initiating it to keep the records to be able to provide them once requested.
Gp Medical Devices Medical Device Recall Simplified Regulations Card Gantt Chart Page 0001

Must-Have Requirements, Recognized Standards, and Certifications:                                                               

  • Registration number, date the report is made, sequence number (001, 002, etc.), “C” for Correction or “R” for Removal.
  • Name, address, phone number, and contact person of the firm responsible for conducting the correction or removal.
  • Manufacturer’s contact information (name, address, phone number, contact person) if different from the item above.
  • Brand name and common name of the device and intended use.
  • Marketing status, i.e., 510(k), PMA, MA, preamendment status, and device listing number.
  • Model/catalog number, lot/serial number.
  • Description of event(s) and the corrective and removal actions that have been, and are expected to be taken.
  • Any illness or injuries that have occurred with the use of the device. 
  • The number of devices subject to the Correction or Removal.
  • Date of manufacture or distribution; expiration date or expected life.
  • Name, address, and telephone number of all consignees (domestic and foreign) and the dates and number of devices distributed to each consignee.
  • A copy of all communications regarding the removal.
  • A statement as to why any required information is not available and a date when it will be submitted.
  • The method(s) to be used for and the level of effectiveness checks from A to E.

Nice-to-have:

Typical Gaps and Deficiencies: Delayed identification of defects, insistent communication with NRA                                 

Implementation Period: Immediately                                                      

Deliverables: Recall notice, Updated information of medical device, De-listing if necessary

PHASE

TASK

TASK

START

DURATION

 

Fee

 

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

 

0

In-house Pre-Submission Activity

       

  0.1

NDA signing or validation

Executor

week 1

1

    

  0.2

Contract Closing

MAH

week 1

1

    

  0.3

POA issuance and shipping

MAH

week 1

1

    

  0.4

Invoice is sent to MAH and paid

Executor

week 1

1

    

  0.5

Legal Document processing

Executor

week 2

1

    

  0.6

Legal Document Translations, Notary, and Apostilles 

3rd party

week 2

2

    

  0.7

SOW is approved by MAH

Executor

week 4

1

   

SOW

I

Recall notification

       

  I.1

Providing documents for recall (investigation results)

MAH

week 5

1

    

  I.2

Translations and document processing

3rd party

week 5

1

    

  I.3

Recall strategy development

Executor

week 6

1

    

  I.4

Recall initiation; info to supply chain and HCP alert 

Executor

week 7

1

    

  I.5

Public warning

Executor

week 7

1

    

  I.6

NRA notification and submission of the Recall report

MAH

week 8

1

   

Notification

  I.7

Communication with NRA

Executor

week 8

1

    

  I.8

Effectiveness checks

Executor

week 9

1

    

  I.9

Recall status report

Executor

week 10

1

   

Report

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

week 11

1

    

  F.2

Final Invoice

Executor

week 11

1

    

  F.3

Final Payment

MAH

week 12

1

    

  F.4

Contract Termination

Executor

week 12

1

    

  F.5

Archiving and limiting access

Executor

week 13

1

   

Archiving

 

Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com