STANDARD OPERATING PROCEDURE
Title: Product Recall Procedure, European Market
Effective Date: _________________
Approvals (Signature and Date):
_____________________________
Responsible Department Head
1.
2.
4.
5.
1.1
To describe the procedure for ensuring a timely and effective retrieval of recalled products distributed
in Europe.
1.2
To assure that the recall is notified in a correct way to the appropriate Competent Authorities if
required.
SCOPE
All products distributed in Europe.
RESPONSIBILITY
3.1
Regulatory Europe is responsible for identifying which recall needs to be notified to which Competent
Authority and to perform the notification as required.
3.2
Customer Service Europe and Marketing Europe are responsible for executing and monitoring the
effectiveness of the recall.
3.3
Quality Assurance Europe is responsible for supervising the complete recall procedure and for
assuring that all documentation is collected and filed.
REFERENCES AND APPLICABLE DOCUMENTS
4.1
Medical Device Directive (93/42/EEC)
4.2
Final draft guidelines on a medical device vigilance system (5/93)
4.3
09-0178-SOP-1.0, Medical Device Reporting (Europe)
4.4
10-0015-SOP-1.0, European Product Traceability Procedure
4.5
10-0027-SOP-1.0, Scrap Procedure Europe
MATERIALS AND EQUIPMENT
5.1
6.
____________________________
Quality Assurance
PURPOSE
2.1
3.
____________________________
Technical Authority
None.
HEALTH AND SAFETY CONSIDERATIONS
6.1
None.
Property of Doxpub, Inc.
All proprietary rights reserved.
09-0141-SOP-1.0
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7.
8.
DOCUMENTATION REQUIREMENTS
7.1
Customer Action Report
7.2
MDR report
7.3
Product Recall Action Report
7.4
Advisory Notice
NOTIFICATION PROCEDURE
8.1
If the Manufacturer determines that the appropriate action is the recall of a product, this procedure is
initiated. The Manufacturer immediately informs Regulatory Europe.
8.2
Regulatory Europe determines whether the recall needs to be notified to the appropriate Competent
Authority.
8.2.1
8.3
If required Regulatory Europe notifies the recall to the appropriate Competent Authorities immediately
(within 24 hours of recall decision) on learning of them.
8.3.1
8.4
9.
A systematic recall by the manufacturer of the same type (lot number/lot numbers) of medical
devices requires notification of the appropriate Competent Authorities if the recall is the result
of any technical or medical reason connected with the characteristics or performance of a
product which might lead to or might have led to the death of a patient or user or to a serious
deterioration in his state of health.
Regulatory Europe performs the notification by sending copies of advisory notices
implementing recalls to the Competent Authority of the countries to which they are applicable
before or at the same time as the notices are sent to the relevant users.
Regulatory Europe immediately informs the European Customer Service, Marketing, Sales, Clinical
Department and Quality Assurance.
RECALL PROCEDURE
9.1
Initial Action
9.1.1
Customer Service Europe immediately blocks all shipments of the batches involved.
9.1.2
Customer Service Europe provides the reconciliation information, through identifying the
quantity of the product lot received in inventory, remaining in inventory, and left inventory
through shipping or scrapped.
9.1.3
Customer Service Europe provides as well the traceability information, meaning providing a
list of all customers who received the concerned batch, and the total number of units shipped
to each.
9.1.4
Quality Assurance Europe put all remaining products of the concerned batch in quarantine,
following 10-0027-SOP-1.0, Scrap Procedure Europe.
Property of Doxpub, Inc.
All proprietary rights reserved.
09-0141-SOP-1.0
Page 2 of 5