Significant Change Notification
Company name:
………….
Company address:
………….
Contact Person/
Date
………….
For guidance on significant changes please refer to Notified Body Recommendation NB-MED/2.5.2/Rec2, Rev. 8
Product related change:
System related change:
Applies to changes of high risk products approved
through Design Dossiers or Type Examinations
Applies to significant changes to the quality management
system
Please list all related TRLP certificate(s):
………….
………….
(only for Annex III or Annex II.4 certificates)
(for all other certificates)
Product line extension, additional model
New Company or Legal Entity name and/or
address
Change of model number/identifier
New products NOT within approved product
subcategories (class IIa) or groups (class IIb)
Change of intended use (e.g. indications,
contra-indications, warnings)
Change of design or manufacturing facilities
Changes in the approved design (e.g.
specifications, materials, packaging, safety
related functions, etc.)
New External Manufacturing Facility (EMF) or
critical supplier
Change of performance data (e.g. shelf life)
Change in quality system (e.g. significant
reorganizations, or changes in QMS structure)
Additional accessories
Change of authorized European
representative
Others
Change in manufacturing or inspection
process
Change of special processes (eg sterilization
processes or facilities)
Others
Remarks:
Significant changes are often related to both products and systems; multiple checks might be required.
Depending on the nature of the change, onsite audits or documentation reviews may be required.
QMZ 40-39-01-GB.doc
Rev. 1; 2011-05-16
Page 1 of 2
Significant Change Notification
For product additions or changed production related facilities the attachment of the TÜV
Rheinland forms “Product List and Application MDD, AIMDD” or in case of IVDD “Product
Description Form” is required.
If not otherwise agreed, please list on the “Product List and Application MDD, AIMDD” only
the product additions and changed production facilities in question.
Brief description of the changes:
………….
Additional Documents attached:
New Application (s)/new contract
Certificates of the sterilization facility
Declaration of Conformity
EMF Certificates, QS certificates,
Approvals issued by a Notified Body
Directions for Use (DFUs) and labels
Essential Requirements checklist
Risk Analysis
Others: ___________________________
Remark:
Significant changes to a design dossier require the submission of revised design dossier contents related to the
change.
QMZ 40-39-01-GB.doc
Rev. 1; 2011-05-16
Page 2 of 2