Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

The aim of this checklist is to summarize the provisions defined in the certified QM system
that cover the manufacturing of certified medical devices for the processes of sterility
assurance (sterilization) and packaging for terminally sterilized devices. This data will be
assessed as part of quality management certification and surveillance. The summary will
enable a directed and less iterative conformity assessment.
Of special interest are the requirements defined for triggering validation activities, the content
of validation activities and their extent. The provisions shall assure that the QM system leads
to the right conclusions for the processes, equipment and changes. The aim is to assure that
substantial changes are identified and notified to the Notified body for further approval.
Further guidance on reportable substantial changes is given at the end of this document.
In case of a complex documentation situation (e.g. multiple sterilization modalities in use) a
separate checklist for each sterilization modality (EO, Irradiation, Moist heat …) may be
beneficial or additional sections may be added in the document

[X] in this document: indicates a document to be referenced including page number. The
respective document shall be part of the submitted documents for the assessment. Grey-
colored guidance text provides additional explanatory information.
In case not all information to a specific requested item can be found within a single evidence
document, please use specific document(s) and page(s) references, e.g. [Doc123, p. 3+4+8]
for each individual bullet point.

1 QUALITY MANAGEMENT SYSTEM IN RELATION TO

PACKAGING FOR TERMINALLY STERILIZED DEVICES:
Note: Please replace italic text with respective information.
Procedures relating to Packaging for Terminally Sterilized Devices
1.1
QM provisions describing The QM provisions are expected to address:
handling of equipment changes,
relocations of packaging a) Contract packager
processes and if necessary, How is it assured:
requirements when revalidation  that appropriate validation (e.g. full / reduced) activities are
triggered at the addition of a new contract packager/lines
is performed (including handling
 Supplier control see item (e) below.
of new packaging technologies):
EN ISO 11607-1, 9 EN ISO Evidence documented in [X,p.y]
11607-2, 5.7, MDR, Article 120
MDCG 2020-3, Chart E b) Packaging equipment (machine, tool)
 How does the QM system assure qualification and validation
including IQ, OQ and PQ for each internal (manufacturer owned)
piece of equipment and process for each operating principle (fully
automated, semi-automated, manual…)?
 What is the statistical basis (i.e. appropriate sample sizes) for
each validation activity and test and how are appropriate
procedures applied?
 For external equipment please refer to the sections on “new
contract packager” and “supplier control”

Evidence documented in [X,p.y]

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 1 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

c) Relocation of equipment
How does IQ ensure that:
 all applicable media (e.g. electricity, air) are re-connected as in the
original setup under consideration of potential mechanical impacts
(e.g. vibration).
 Machine operation and maintenance are kept the same.

 How does the revalidation extent (OQ and PQ) for the equipment
take into account:
o if equipment is disassembled / maintained
o moved assembled

 In case of revalidation, how is the output for” equivalency” as

described under the point “new sealing parameters” met?

Evidence documented in [X,p.y]

d) Supplier control
How is it assured:
 that appropriate certification and supplier control is established
and continuously verified?
 that external suppliers use qualified equipment and validated
processes?
 that appropriate quality agreements are in place how to handle
changes in products, processes and responsibilities?
 that these agreements assure the manufacturer possesses all
relevant validation data from the supplier in his technical
documentation?

Evidence documented in [X,p.y]

e) If applicable: Equipment equivalency:

How are the prerequisites/provisions for equivalence defined in the QM
system?

 For a new candidate equipment of identical technology, as already

in use, processing the identical material as the previously
validated equipment, how is it assured:

o that (IQ), OQ, PQ for each individual candidate

equipment is available and acceptance criteria are met?
o that candidate equipment is compared to the predicate
equipment with defined requirements / acceptance
criteria:
o the output of candidate equipment (e. g. seal strength at
upper/nominal/lower limit) is within the validated window
(e.g. seal strength ±%) of the predicate equipment
o packaging properties are maintained: seal width,
peelability, seal integrity, absence of unacceptable
material delamination
 that a documented conclusion is present for the new equipment
why the predicate design validation can be leveraged based on
comparison
 that in the case of no equivalency can be established, a full
validation shall be triggered.

Evidence documented in [X,p.y]

f) New sealing parameters

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 2 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

 If applicable: Description how new process parameters or

machines setting are evaluated to be equivalent with regards to
the delivered output parameters at sealing (using adequate
statistics, justified acceptable tolerance/variation in seal strength
(and optional other parameters) in +-% from the fully validated
process (of predicate equipment)
 How are packaging properties maintained: seal width, peelability,
seal integrity, absence of unacceptable material delamination

Evidence documented in [X,p.y]

g) New forming parameters

 In case of process parameters (setpoints) deviating from the
predicate validated process - how is it assured that the output data
such as essential dimensions meet the validated design?

Evidence documented in [X,p.y]

h) Are there any requirements for a time-based revalidation?

 What interval is set to regular revalidation of the packaging
process?
Evidence documented in [X,p.y]
1.2 QM provisions describing How do the QM system provisions address the impact of product changes
requirements on product on the packaging process as well as design? How do the QM system
adoption for new designs provisions define criteria that trigger an adequate partial or full revalidation?

How are the following aspects addressed:

MDR, Article 120
MDCG 2020-3, Chart E
EN ISO 11607-1, 9 a. New packaging material
EN ISO 11607-2, 5.7 In case of new packaging material, how is EN ISO 11607-1 compliance
ensured in terms of the following:
 related physical data sheets meet a pre-defined specification:
Critical parameters may be (but not limited to) minimum tensile
strength, tear resistance, puncture resistance, air permeance,
microbial barrier properties, thickness, chemical property and
dimensions
 suitability is adequate to not compromise biocompatibility of the
packed product (e.g. cytotoxicity acc. ISO 10993-5 or USP).

Evidence documented in [X,p.y]

b. New packaging design

 How are changes in dimensions of the packaging design going
through a risk assessment regarding potential impact on the
validated predicate packaging design including usability?
 How are changes in venting capability of packaging (e.g. label on
breathable packaging portion), assessed regarding impact on
sterilization?
 How are changes in number of sterile barriers and protective
packaging addressed by an assessment of the impact on
sterilization, transport and usability?
 How is it assured that completely new sterile barriers are fully
validated (including performance testing and ageing)?

Evidence documented in [X,p.y]

c. New product design

 How are risks assessed regarding the potential impact on the
validated predicate packaging process and design, if there are
changes in dimensions of the product design (e.g. fitting of device
in predicate packaging)?

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 3 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

 How is it assured that a new process and design validation is

triggered, in case of a new worst-case e.g product interacts with
the packaging seal during sealing?

Evidence documented in [X,p.y]

d. Extension of shelf life

 In case of shelf-life extension, how is a new packaging stability
study (accelerated and real time study) covering the claimed shelf
life triggered?

Evidence documented in [X,p.y]

e. Packaging equivalence:
 How is a conclusion drawn on a comparison of the candidate
product and the fully validated predicate product under
consideration of:
o product aspects such as dimensions, geometry, weight,
material, surface, sharp edges, chemical property
equivalence determined by chemical method (e.g. IR
spectroscopy)
o sterile Barrier System (SBS) aspects such as design,
materials, dimensions, freedom of movement of product
within SBS etc.
o protective packaging aspects such as components (shelf
box, shipper box, etc), materials, number of SBS in shelf-
box, number of shelf-boxes in shipper, etc.
o materials not meeting the predicate material specification
(set point ± tolerance) result in a full process and design
validation

Evidence documented in [X,p.y]

1.3 QM provisions describing What provisions in the QM system are defined to ensure that packaging
requirements to identify process changes as well as design changes are evaluated with regards to
significant changes related to their significance?
packaging to be notified to the
Notified Body Are actions defined if equivalency between predicate (equipment, process,
MDR, Article 120 packaging design and performance with impact on sterility) and candidate
MDCG 2020-3, Chart E situation cannot be demonstrated?
EN ISO 11607-1, 9
EN ISO 11607-2, 5.7 Evidence documented in [X,p.y]

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 4 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

2 QUALITY MANAGEMENT SYSTEM IN RELATION TO

STERILIZATION
Quality Management provisions in relating to sterilization
2.1
QM provisions describing For all sterilization modalities:
handling of equipment changes
or relocations of sterilization a. Contract steriliser
processes and if necessary, How is it assured:
requirements when revalidation  that a process validation (PQ) is triggered and that sterilizing agent
is performed (including handling residual levels are addressed (if applicable)?
of new sterilization  if new sterilization lines (chambers, irradiators) are added at a
technologies): contract sterilizer, these lines have to be added either by reduced
[EN ISO 13485, 7.5.6 + 7.5.7] or full PQ, depending on if equivalence data is available?
 that IQ / OQ was done for the equipment in question?
EN ISO 11135, 5.5, 6.3, 7.1.2
 for external equipment please refer to the section on “supplier
9.2, 9.3, 9.4, 9.5, 10, 12.3.1,
control”
12.3, Annex A, Annex B
EN ISO 11737-2
Evidence documented in [X,p.y]
EN ISO 11137-1: 5.1.2 6.2, 7.5
7.6, 8.2, 9.2, 9.3, 9.4.11, 12.2,
11.1, 12.3 12.4, 12.5 A.12.5.1 b. Sterilization equipment:
Tables A.1, A.2, A.3, What provisions are in place regarding the following topics:
EN ISO 11137-2 4.4 6  the QM system assures qualification and validation including IQ,
EN ISO 11137-3 9.2 9.3 OQ and PQ of each internal piece of equipment and process for
EN ISO 17665 6.1, 6.2, 8.1 8.10 each sterilization modality?
8.11, 9.1.6, 9.1.7, 9.1.8, 9.2, 9.3  IQ: state of the art standards are used (e.g. EN 1422, EN 285)?
9.4 9.5, 10.3 12.2 EN 285  OQ: What are the minimum requirements for the operational
B.8.3.1.1 qualification of the equipment?
o Is the number of sensors/dosimeters to be used defined?
EN ISO 14937 6.2, 6.3 8.2 9.4
12.5.2  PQ: How is it ensured that the cycle works within the defined
process boundaries considering minimum and maximum load
configurations. Are mixed loads possible/considered?
 that the effect of the sterilization process on product safety and
functionality is being assessed?
 to ensure that BIs/PCDs are still appropriate for use in the new
equipment?
 for external equipment please refer to the section on “supplier
control”

Evidence documented in [X,p.y]

c. Supplier control
How is it assured:
 that appropriate certification and supplier control is established?
 that external suppliers use qualified equipment and validated
processes?
 that appropriate quality agreements are in place how to handle
changes in products, processes and responsibilities?
 that these agreements assure the manufacturer possesses all
relevant validation data from the supplier in his technical
documentation?

Evidence documented in [X,p.y]

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 5 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

d. If applicable: Equipment & process equivalency:

What provisions for acceptance of equivalency are defined for a new
candidate equipment or process? How were the following aspects taken
into account?
 (IQ), OQ, PQ for each individual candidate equipment
 Strategy on how the candidate equipment is compared to the
predicate equipment.
 Process outputs shall be equal within pre-defined statistical limits
(process capability in relation to delivered processes that are
equivalent is adequately shown).
 In the case equivalency cannot be concluded a full validation shall
be triggered.

Evidence documented in [X,p.y]

e. New sterilization parameters

In relation to new cycle parameters for sterilization - How it is assured that:
 Operational parameters running outside established validated
boundaries need an own validation
 That product properties are maintained: Are functional product
tests done to assure product conformity is maintained?

Evidence documented in [X,p.y]

f. Are there any requirements for a time-based revalidation?

 What interval is set to regular revalidation of the sterilization
process?
 What interval is set to reassure product families are still valid?

Evidence documented in [X,p.y]

2.2 QM provisions describing How do the QM system provisions address the impact of product changes
actions triggered by new on the sterilization process? How do the QM system provisions define
products, adoption for new criteria which trigger an adequate partial of full revalidation?
designs to existing product
families How are the following aspects taken into account:
EN ISO 11737-1,
a) New product design/manufacturing step
A.7.2.1, A.5.1.2
 How are risks assessed regarding potential impact on the
EN ISO 11135 D.7.1.2 12.5
validated predicate design related to changes in dimensions of the
AAMI TIR 28 design or mass and material of the product?
EN ISO 11137-2:  How is the impact on sterilization assessed by changes in venting
4.2.2, 4.2.1, 4.2.3, 4.2.4 capability of the product?
EN ISO 11137-1:  How is it assured that in case of a new worst-case, new process
7.5, 17665: 12.4, 12.5 and design validation is triggered?
 How are resulting changes in manufacturing/material handled that
lead to changes in bioburden levels, changed residues level and
product functionality (related to sterilization)?
 How is the impact of product changes on the validated load
configuration verified?

Evidence documented in [X,p.y]

b) Product/process equivalence:
In this context, how are candidate products compared to existing (predicate)
devices?

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 6 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

 Is e.g. AAMI TIR 28 / EN ISO11135 Annex D.7.1.2 adapted for EO

processes?
 How are key elements like bioburden, sterilizability, density and
residuals based on diffusion barriers and pathways of the sterilant
considered?
 What provisions are in place if a new (potential) worst-case
constellation is identified? What actions are performed as a
consequence?
 At what stage of the equivalency assessment is a sterilization
specialist involved/approving the decision?

Evidence documented in [X,p.y]

2.3 QM provisions to identify What provisions in the QM system are defined to ensure that changes in
significant changes related to sterilization affecting product conformity (e.g. residuals) are evaluated for
sterilization to be notified to the their impact and a decision is drawn whether to inform the Notified Body?
Notified Body
MDR, Article 120 Impacts may be but are not limited to changes of:
MDCG 2020-3, Chart E  sterilization process (e.g. cycle specs)
EN ISO 11135 12.4  manufacturing process (e.g. bioburden, Endotoxins)
EN ISO 11137-1 12.5  design with impact on sterility (e.g. material compatibility,
EN ISO 17665-1 12.5 packaging, diffusion pathways)
EN ISO 14937 12.5
Evidence documented in [X,p.y]

How are the following aspects considered?

a. Change of load or packaging

 How are any changes in packaging or load composition evaluated
regarding sterilization aspects? (e.g. density changes, changes of
gas diffusion pathways, mass or volume etc.)

Evidence documented in [X,p.y]

b. Change on equipment
 What provisions are in place that assure that equipment changes,
or major repairs will be assessed on their sterilization impact to
potentially trigger revalidation or parts of the validation process?

c. Change of Bioburden controls/ specification / cleanliness

 How are changes in bioburden control steps (e.g. cleaning or
disinfection) (bioburden quality or quantity) evaluated regarding
their impact on SAL and residuals (e.g. endotoxins)?
 How are limits for bioburden control established (history of
bioburden, how is the relation to the acceptable count allowed
going into sterilization)?
 If alert/action limits are increased, how is it assured that the
existing cycle still achieves the required SAL?
 How are microbiological Out of Specification (OOS) results
handled and followed up? (e.g. elevated bioburden, pyrogen
results)

Evidence documented in [X,p.y]

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 7 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

3 QUALITY MANAGEMENT SYSTEM IN RELATION TO

PROCESSING INSTRUCTIONS FOR REUSABLE DEVICES – IF
APPLICABLE

Procedures relating to reuse

3.1
Provisions describing the What decision rules on significance of device or IFU changes in relation to
interface to change safe processing are defined?
management for processing
instructions: Evidence documented in [X,p.y]

3.2 What provisions are defined in the QM system to handle the following
Development procedure for aspects:
reusable/initially to be processed
devices related to the a) Development of new devices:
instructions for processing:
product adoption strategy including decision criteria for new validation
Evidence documented in [X,p.y]

b) The validation of instructions for use:

The respective procedure is expected to address reprocessing acceptance

criteria (cleaning, disinfection, sterilization, biocompatibility and
functionality), justified limits and test soil selection with scientific rationales
based on the risk assessment (refer also to EN ISO 17664-1 5).
Evidence documented in [X,p.y]

c) If applicable: grouping strategy of product family:

Grouping strategy and worst-case product selection for cleaning,

disinfection, sterilization, lifetime studies including biocompatibility and
functional testing
Evidence documented in [X,p.y]

d) Risk management considering aspects of reuse and/or (initial)

processing:

At least the relevant points according to EN ISO 17664-1, clause 5 are

expected.
Evidence documented in [X,p.y]

e) National reprocessing requirements of EU member states:

Provisions for systematic search for and handling of national reprocessing

requirements of EU member states, where the devices are placed on the
market
Evidence documented in [X,p.y]

f) Requirements in relation to qualification of personnel regarding

the assessment of reuse/biocompatibility data:

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 8 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Trainings, CV related to EN ISO 17664-1 of involved decision maker of e.g.

grouping of devices, instructions for reprocessing, product adoption, …
Evidence documented in [X,p.y]

3.3
Provisions on Post Market
Evidence documented in [X,p.y]
Surveillance in relation to
reuse/processing?

Regulatory
release by
client:
Date Signature Name

Name of Legal Manufacturer

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 9 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Informative Annex on significant changes to be reported to the Notified Body under

MDR/IVDR and transition period under Article 120 MDR/ 110 IVDR
Sterilization Class Is-IIb (with exceptions)
Only under
presumption that
the QM system
foresees the right
risk analysis and/or
validation work.
Green becomes
red if presumption
is not met!

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 10 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Sterilization Class Is-IIb (with exceptions) Transition Period per Article 120 MDR and
110 IVDR

Only under New Sterilization Different Transition to MDR/IVDR

presumption that Technology Technology required
the QM system
foresees the right Additional
risk analysis and/or sterilization line at
validation work. contract Sterilizer
New Equipment /
Green becomes
new Supplier
red if presumption New Supplier or
is not met! new Inhouse
Equipment

Minor Changes in
same Process
Release Process
(e.g. Parametric
Release)
New Release
Principle

Limit Increase
(within validated
Change in Range)
Bioburden
Specification
Limit Decrease

Minor Changes
Change in (No pot. Effect on BC
Sterilization for or Product)
low Risk Devices Change in Cycle /
Dose
Parameters out of
validated Range

Out of validated
Range

Change of Load / Within validated

Packaging Range

Negative Impact on
Gas Diffusion

Pot. negative Legend

Change in Impact
Bioburden
Control/ BB No Change
Reduction notification required
Additional/
improved Measures
Change notification
required
New Worst -Case
Product Change Release under §120
(Design) MDR/ §110 IVDR
New Variant is transition period is
covered by
not possible
validated Range

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 11 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Sterilization Class IIb(i) & Class III

New Sterilization Different
Only under Technology Technology
presumption that
the QM system Additional
foresees the right sterilization line at
risk analysis and/or contract Sterilizer
New Equipment /
validation work. new Supplier
Green becomes New Supplier or
new inhouse
red if presumption
Equipment
is not met!

Minor Changes in
same Process
Release Process
(e.g. Parametric
Release)
New Release
Method

Limit Increase
(within validated
Change in Range)
Bioburden
Specification
Limit Decrease

Minor Changes
Change in (No pot. Effect on BC
Sterilization for or Product)
high Risk Devices Change in Cycle /
Dose
Parameters out of
validated Range

Out of validated
Range

Change of Load / Within validated

Packaging Range

Negative Impact on
Gas Diffusion

Pot. negative
Change in Impact
Bioburden
Control/ No Change
Reduction Additional/ n
improved Measures
Change n
required
New Worst-Case
Product Change Release under§120
(Design) MDR/ §110 IVDR
New Variant is
covered by
validated Range not possible

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 12 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Sterilization Class IIb(i) & Class III Transition Period per Article 120 MDR and 110 IVDR
New Sterilization Different
Technology Technology Transition to MDR/IVDR required
Only under
presumption that
the QM system Additional
foresees the right sterilization line at
risk analysis and/or contract Sterilizer
New Equipment /
validation work. new Supplier
Green becomes New Supplier or
new inhouse
red if presumption
Equipment
is not met!

Minor Changes in
same Process
Release Process
(e.g. Parametric
Release)
New Release
Method

Limit Increase
(within validated
Change in Range)
Bioburden
Specification
Limit Decrease

Minor Changes
Change in (No pot. Effect on BC
Sterilization for or Product)
high Risk Devices Change in Cycle /
Dose
Parameters out of
validated Range

Out of validated
Range

Change of Load / Within validated

Packaging Range

Negative Impact on
Gas Diffusion

Pot. negative Legend

Change in Impact
Bioburden
Control/ No Change
Reduction Additional/ notification required
improved Measures
Change notification
required
New Worst-Case
Product Change Release under§120
(Design) MDR/ §110 IVDR
New Variant is
covered by transition period is
validated Range not possible

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 13 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Packaging Class Is-IIb (with exceptions) Transition Period per Article 120 MDR and 110
IVDR
New contract new PK
Only under packager processes
presumption that
the QM system same operating
foresees the right principle1
risk analysis
and/or validation different
work. Green New equipment operating
becomes red if principle
presumption is not
met!
Different sealing technology2 e.g. heat sealing vs. ultrasonic sealing

same
specification3
New packaging
material
different
specification

within validated
window4
New sealing
parameter
out of validated
window4

within validated
window4
New forming
Change in parameter
Packaging for low out of validated
risk devices window4

disassembled
relocation of
equipment
assembled

shorter
change of
shelf life
longer5

only for
marginal
changes

new higher number

PACKAGING of sterile barriers
design
Complete new packaging type, new geometry, lower number of sterile
barriers or protective packaging, higher number of devices in a kit,..6

worst case
new PRODUCT
design
no
worst case

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 14 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Legend: 1. Old and new machine are manually guided sealers, or semi-automated sealers, or fully automated sealers,
or…… respectively old and new machine use vacuum forming or pressure forming or negative forming (female)
or positive forming (male), ..
2. e.g. heat sealing vs. ultrasonic sealing
3. Same thickness, material composition, .. – maybe different supplier, but consideration of biocompatibility
needed!
4. Validated window is understood as validated process output (e.g. seal strength +/-10%)
5. Protocol needs to be approved by TÜV SÜD in course of the procedure review, otherwise Art. 120 is triggered
and MDR/IVDR transition period is not possible!
6. Complete new packaging type (e.g. pouch => blister; breathable => non-breathable), new geometry (size,
shape,..), lower number of sterile barriers (e.g. double pouch => single pouch), lower number of protective
packaging, higher number of devices in a kit (for removal of devices in a kit, impact on transport validation shall
be evaluated)

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 15 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Packaging Class IIb(i) & Class III Transition Period per Article 120 MDR and 110 IVDR

New contract new PK

Only under packager processes
presumption that
the QM system
foresees the right same operating
risk analysis principle1
and/or validation
work. Green different
becomes red if New machine operating
presumption is not principle
met!
Different sealing technology2 e.g. heat sealing vs. ultrasonic sealing

same
specification3
New packaging
material
different
specification

within validated
window4
New sealing
parameter
out of validated
window4

within validated
window4
New forming
Change in parameter
packaging for high- out of validated
risk devices window4

disassembled
relocation of
equipment
assembled

shorter
change of
shelf life
longer

only for
marginal
changes
higher number
new of sterile
PACKAGING barriers
design

Complete new packaging type, new geometry, lower number of sterile

barriers or protective packaging, higher number of devices in a kit,..5

worst case
new PRODUCT
design
no worst case

Legend: 1. Old and new machine are manually guided sealers, or semi-automated sealers, or fully automated sealers,

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 16 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

or…… respectively old and new machine use vacuum forming or pressure forming or negative forming (female)
or positive forming (male), ..
2. e.g. heat sealing vs. ultrasonic sealing
3. Same thickness, material composition, .. – maybe different supplier, but consideration of biocompatibility
needed!
4. Validated window is understood as validated process output (e.g. seal strength +/-10%)
5. Complete new packaging type (e.g. pouch => blister; breathable => non-breathable), new geometry (size,
shape,..), lower number of sterile barriers (e.g. double pouch => single pouch), lower number of - protective
packaging, higher number of devices in a kit (for removal of devices in a kit, impact on transport validation shall
be evaluated);

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 17 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Packaging Class Is-IIb (with exceptions)

New contract new PK
Only under packager processes
presumption that
the QM system same operating
foresees the right principle1
risk analysis and/or
validation work. New different
Green becomes red equipment operating
if presumption is principle
not met!
Different
technology2

same
specification3
New packaging
material
different
specification

within validated
window4
New sealing
parameter
out of validated
window4

within validated
window4
Change in New forming
Packaging for low parameter
out of validated
risk devices window4

disassembled
relocation of
equipment
assembled

shorter
change of
shelf life
longer5

only for
marginal
changes
new
PACKAGING higher number
design of sterile
barriers

See6

worst case
new PRODUCT
design
no
worst case

Legend: 1. Old and new machine are manually guided sealers, or semi-automated sealers, or fully automated sealers, or
respectively old and new machine use vacuum forming or pressure forming or negative forming (female) or

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 18 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

positive forming (male), ..

2. e.g. heat sealing vs. ultrasonic sealing
3. Same thickness, material composition, .. – maybe different supplier, but consideration of BC needed!
4. Validated window is understood as validated process output (e.g. seal strength +/-10%)
5. Protocol needs to be approved by TÜV SÜD in course of the procedure review, otherwise Art. 120 is triggered
and MDR/IVDR transition period is not possible!
6. Complete new packaging type (e.g. pouch => blister; breathable => non-breathable), new geometry (size,
shape,..), lower number of sterile barriers (e.g. double pouch => single pouch), lower number of protective
packaging, higher number of devices in a kit (for removal of devices in a kit, impact on transport validation shall
be evaluated)

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 19 of 21
 Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Packaging Class IIb(i) & Class III

New contract new PK
Only under
packager processes
presumption that the
QM system foresees the
same operating
right risk analysis principle1
and/or validation work.
Green becomes red if different
presumption is not met! New machine operating
principle

Different
technology2

same
specification3
New packaging
material
different
specification

within validated
window4
New sealing
parameter
out of validated
window4

within validated
window4
New forming
parameter
Change in out of validated
packaging for window4
high-risk devices

disassembled
relocation of
equipment
assembled

shorter
change of
shelf life
longer

only for
marginal
changes

higher number
new of sterile
PACKAGING barriers
design

See5

worst case
new PRODUCT
design
no worst case

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 20 of 21
Form – CONFIDENTIAL

Client Checklist Quality Management Provisions for

Sterilization & Sterile Packaging

Legend: 1. Old and new machine are manually guided sealers, or semi-automated sealers, or fully automated sealers,
or…… respectively old and new machine use vacuum forming or pressure forming or negative forming (female)
or positive forming (male), ..
2. e.g. heat sealing vs. ultrasonic sealing
3. Same thickness, material composition, .. – maybe different supplier, but consideration of biocompatibility
needed!
4. Validated window is understood as validated process output (e.g. seal strength +/-10%)
5. Complete new packaging type (e.g. pouch => blister; breathable => non-breathable), new geometry (size,
shape,..), higher number of sterile barriers (e.g. single pouch => double pouch), lower number of sterile barriers
(e.g. double pouch => single pouch), lower number of protective packaging, higher or lower number of devices in
a kit

ID: 225973 Doc No: MED_T_09.06 Revision: 2 - released Effective: 12 Apr 2024 Page 21 of 21