Procedure Packs and new obligations of procedure pack

producers
Questions and Answers – INTERNAL
Version 2.0; March 2020 (replaces v 1.0 of January 2020)

DISCLAIMER

The IVDR and MDR contain several provisions that are capable of being given more than one interpretation.
In the preparation of this Guidance, MedTech Europe has used its best efforts to ensure that the opinions
and advice expressed are sound. However, the Association makes no assertion that those opinions and
advice are correct, and it accepts no legal responsibility for them. Specific legal advice should be sought
before acting on any of the topics covered. MedTech Europe reserves the right to change or amend this
document at any time without notice in order to keep the information up to date.

Members are reminded that, while competent authorities and notified bodies may be helpful in providing
views as to the meaning of the IVDR and MDR Regulation, it is ultimately for the courts to interpret legislation

This Q&A document has been developed by the MedTech Europe Procedure Packs AhWG with input from
the MedTech Europe UDI WG. This document is internal and hence for industry use only.

CONTENTS:
DEFINITIONS
Chapter 1: TRANSITION PERIOD
Chapter 2: LABELLING – PACKAGING
Chapter 3: STERILISATION
Chapter 4: *NEW: VIGILANCE
Chapter 5: *NEW: EUDAMED & UDI
Chapter 6: OBLIGATIONS OF THE PPP

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DEFINITIONS

Procedure Pack Producer: PPP.

= natural or legal person who places the PP on the market (as per MDR).

As per MDCG 2018-3 Guidance on UDI for systems and procedure packs, the natural or legal person referred
to in Article 22(1), 22(2) and 22(3) of the Medical Device Regulation shall be called the "system or procedure
pack producer".
The PPP is defined as an economic operator as per MDR Art.2. (35). Obligations of manufacturer are not
applicable.
For more information on economic operators in general and their respective obligations, the MTE material
on Economic operators can be consulted.

Procedure Pack: PP
= a combination of products packaged together and placed on the market with the purpose of being used for
a specific medical purpose (MDR definition as per Art.2 (10)).

Examples: first aid kits, orthodontic procedure packs and skin traction kits (as per MDCG 2018-3 Guidance
on UDI for systems and procedure packs).

Procedure pack file: PPF

= documentation to support compliance with MDR Article.22.1 -22.3.
This terminology is used by the MTE Ad Hoc Group on PP to distinguish the Procedure packs documentation
from the technical documentation/technical file of the original manufacturer. This is not an MDR defined term
as such.

These abbreviations will be used throughout this document.

SCOPE

This guidance covers Procedure Packs marketed under MDR Art. 22, except for 22.4 as these are considered
devices in their own right and they follow requirements for devices. The producer of a PP which falls under
22.4. is considered a manufacturer and follows manufacturer’s obligations in this case.
The PPP is defined as an economic operator as per MDR Art.2. (35). Obligations of manufacturer are not
applicable.

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 1. TRANSITION PERIOD

1. Question: MDR vs MDD compliant procedure – what changes?

Answer: Although articles 12 of the MDD and article 22 of the MDR do not differ substantially from
each other. The MDR introduces additional requirements for procedure packs, specifically Eudamed
and UDI requirements.

Key changes – new requirements for a MDR compliant PP:

• The PPP is considered economic operator and registers as such in Eudamed and needs to
obtain an SRN applicable to their role (MDCG 2018-3).
• Registering the PP. MDCG 2018-3 (MDR Art.29.2)
• Traceability; UDI assignment and UDI registration (Art.29.2, MDCG 2018-3)
• ‘’Procedure pack file’’ (explained on p.3), including labelling requirements; per MDR art. 22.5
• Vigilance and post-market surveillance (based on HPRA guidance for the moment. No legal
basis in MDR as of today but regulators are looking into creating a legal interpretation for
this.)

Article 12 MDD; Particular procedure for

systems and procedure packs and Article 22 MDR; Systems and procedure packs
procedure for sterilisation

1. By way of derogation from Article 11 this 1. Natural or legal persons shall draw up a
statement if they combine devices bearing a CE
Article shall apply to systems and
marking with the following other devices or
procedure packs. products, in a manner that is compatible with the
intended purpose of the devices or other products
2. Any natural or legal person who puts and within the limits of use specified by their
devices bearing the CE marking together manufacturers, in order to place them on the
market as a system or procedure pack:
within their intended purpose and within
the limits of use specified by their (a) other devices bearing the CE marking;
manufacturers, in order to place them on (b) in vitro diagnostic medical devices
the market as a system or procedure pack, bearing the CE marking in conformity with
shall draw up a declaration by which he Regulation (EU) 2017/746;
(c) (c) other products which are in conformity
states that:
with legislation that applies to those
products only where they are used within
(a) he has verified the, mutual a medical procedure or their presence in
compatibility of the devices in accordance the system or procedure pack is otherwise
justified.
with the manufacturers' instructions and
has carried 2.In the statement made pursuant to paragraph 1,
out his operations in accordance with the natural or legal person concerned shall
these instructions; and declare that:

(a) they verified the mutual compatibility of

the devices and, if applicable other

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 (b) he has packaged the system or
procedure pack and supplied relevant
information to users incorporating relevant
instructions from the manufacturers; and
(c) the whole activity is subjected to
appropriate methods of internal control
and inspection.
Where the conditions above are not met,
as in cases where the system or
procedure pack incorporate devices which
do not bear a CE marking or where the
chosen combination of devices is not
compatible in view of their original
intended use, the system or procedure
pack shall be treated as a device in its own
right and as such be subjected to the
relevant procedure pursuant to Article 11.
3. Any natural or legal person who
sterilises, for the purpose of placing on the
market, systems or procedure packs
referred to in
paragraph 2 or other CE-marked medical
devices designed by their manufacturers
to be sterilised before use, shall, at his
choice, follow one of the procedures
referred to in Annex II or V. The application
of the
abovementioned Annexes and the
intervention of the notified body are limited
to the aspects of the procedure relating to
the obtaining of sterility until the sterile
package is opened or damaged. The
person shall draw up a declaration stating
that sterilisation has been carried out in
accordance with the manufacturer's
instructions.
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products, in accordance with the
manufacturers' instructions and have
carried out their activities in accordance
with those instructions;
(b) they packaged the system or procedure
pack and supplied relevant information to
users incorporating the information to be
supplied by the manufacturers of the
devices or other products which have
been put together;
(c) the activity of combining devices and, if
applicable, other products as a system or
procedure pack was subject to
appropriate methods of internal
monitoring, verification and validation.
3.Any natural or legal person who sterilises
systems or procedure packs referred to in
paragraph 1 for the purpose of placing them on the
market shall, at their choice, apply one of the
procedures set out in Annex IX or the procedure
set out in Part A of Annex XI. The application of
those procedures and the involvement of the
notified body shall be limited to the aspects of the
procedure relating to ensuring sterility until the
sterile packaging is opened or damaged. The
natural or legal person shall draw up a statement
declaring that sterilisation has been carried out in
accordance with the manufacturer's instructions.
4.Where the system or procedure pack
incorporates devices which do not bear the CE
marking or where the chosen combination of
devices is not compatible in view of their original
intended purpose, or where the sterilisation has
not been carried out in accordance with the
manufacturer's instructions, the system or
procedure pack shall be treated as a device in its
own right and shall be subject to the relevant
conformity assessment procedure pursuant to
Article 52. The natural or legal person shall
assume the obligations incumbent on
manufacturers.
5.The systems or procedure packs referred to in
paragraph 1 of this Article shall not themselves
bear an additional CE marking but they shall bear
the name, registered trade name or registered
trade mark of the person referred to in paragraphs
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 4. The products referred to in paragraphs
2 and 3 themselves shall not bear an
additional CE marking. They shall be
accompanied by the information referred
to in point 13 of Annex I which includes,
where appropriate, the information
supplied by the manufacturers of the
devices which have been put together.
The declarations referred to in paragraphs
2 and 3 shall be kept at the disposal of the
competent authorities for a period of five
years.
1 and 3 of this Article as well as the address at
which that person can be contacted, so that the
person's location can be established. Systems or
procedure packs shall be accompanied by the
information referred to in Section 23 of Annex I.
The statement referred to in paragraph 2 of this
Article shall be kept at the disposal of the
competent authorities, after the system or
procedure pack has been put together, for the
period that is applicable under Article 10(8) to the
devices that have been combined. Where those
periods differ, the longest period shall apply.

2. Question: What regulatory regime shall apply to class I devices self-certified under the
directives in order to be included in the PP?

Answer: Self-certified class I medical devices shall be fully compliant with the MDR by 26 May 2020
in order to be placed on the market after that date. However, if the requirements of MDR applicable
to them imply the intervention of a Notified Body such devices will fall under the art. 120 (3), as
amended by the 2nd corrigendum of 27 December 2019.
PPP should verify that the class I device is MDR compliant by the date of application (DoA).

Self-certified class I medical devices placed on the market before the DoA may be put in a PP and
made available on the market/put into service until 27 May 2025. This is based on Art.120.4. MDR.
In the case of a reusable procedure pack, if the MDD product has been timely placed on the market
(in line with the transitional provisions of MDR Art.120 ) was provided to a hospital (user) before 28
May 2025 (put into service) in a PP, the MDR would then not restrict its further use in a PP after 27
May 2025.

3. Question: What regulatory regime shall be followed after the DOA in the following scenarios?

1. Procedure packs containing exclusively devices CE marked according to the MDR

2. Procedure packs containing both devices which are CE marked according to MDD/AIMDD
or according to MDR
3. Procedure packs containing exclusively devices CE marked according to the MDD/AIMD

Answer: PP shall follow the MDR as of DOA – for all scenarios.

Note: A pack including an MDR device before 26 May 2020 may follow Article 12 of the MDD. Any
devices that have been placed on the market before 26 May 2020 or the expiry date of the MDD

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 certificate may continue to be made available and put into service as part of a procedure pack until
27 May 2025.

4. Question: what does the PPP need to do differently under the MDR regime?

Answer:
• Article 22 Statement
• Add name and address of person identified in Article 22 statement to procedure pack.
• Review relevant documentation supporting the CE marking of the device, and
documentation relevant to the compatibility of the devices within the PP (see also Q15)
• Update information supplied with the PP to reflect updated MDR information from device
manufacturers, including new patient information and implant cards as they become MDR
compliant
• Register 1 the PPP as an economic operator in Eudamed – by providing data elements listed
in Annex VI Part A Section 1 by Date of Application to obtain a Single Registration Number
when Eudamed database is available.
• Register the PP in Eudamed as applicable when Eudamed is available. (See:
definitions/descriptions and formats of the UDI core elements for procedure packs listed in
MDR UDI and device data sets and in UDI device data dictionary posted on the
Commission’s website https://ec.europa.eu/growth/sectors/medical-devices/new-
regulations/eudamed_en.). In the absence of Eudamed, the corresponding provisions of the
MDD/AIMDD will continue to apply (Art 123.3.d).
• Apply UDI carrier to the outside of the procedure pack

5. Question: What are the UDI implications if the PP contains reusable components?

Answer: The PPP will add UDI carrier to the outside of the pack – this is a general requirement. If
the PP contains reusable devices, those shall bear a UDI carrier on the device itself (direct marking)
according to Annex VI Part C 4.10. The manufacturer is responsible for direct UDI marking (Art.
123.3.g)) (not the PPP).

6. Question: Does the PPP need a QMS/procedures updated for MDR as of 25 May 2020?

Answer: The procedures to ensure correct combination of the components need to be validated by
26 May 2020 – a new requirement of MDR (the ‘validation’ was not requested by the MDD).
The PPP does not need a full QMS.

7. Question: Can IVDs CE marked against the IVDD before 26 May 2022 (DOA of IVDR) be
included in an MDR compliant PP before 26 May 2022?

Answer: IVD device certified according to the IVDD before 26 May 2022 is legally placed on the
market and can be included in an MDR compliant PP.
8. What will be the situation during the IVDR grace period (26 May 2022 to 26 May 2024) – can
the Procedure Pack still contain IVDs CE marked based on the IVD directive?

1 The two obligations divided: economic operator registration and device registration since different timelines apply

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 Answer: IVDs certified against the IVDD such as self-tests, and Annex II list A and B will benefit from
the grace period, until 26 May 2024. Hence, they can be placed into a PP until 26 May 2024 with
their IVDD certificate. Please note that this only applies to a very restricted number of IVD devices,

i.e. those that have currently NB certificates. The rest (80% of the IVD industry) does not have an
NB certificate and will have to be compliant to the IVDR on 26 May 2022.

IVD component in a PP will have to be always CE marked, same applies for an MD component in
an IVD kit.

Note: ‘’intended purpose’’ of the PP (MD) and the kit (IVD) are different from each other.

2. LABELLING – PACKAGING

9. Question: What is the minimum information necessary to be provided on the Label of the
procedure packs?

Answer: Labelling considerations are discussed in Clause 5 of Article 22. “The systems or procedure
packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking
but they shall bear the name, registered trade name or registered trade mark of the person
referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can
be contacted, so that the person's location can be established. Systems or procedure packs shall
be accompanied by the information referred to in Section 23 of Annex I…”
Also see article 22.2.b)

Some requirements in section 23 of Annex I, may be met by individual devices within the pack. The
PPP will determine what goes on the PP label (what needs to be repeated from the devices labels
in the pack), ultimately ensuring that the PP can be used safely for its intended purpose.

Minimum information necessary (per Article 22 of MDR) 2

• Name/Registered Trade Name of the Procedure Pack

• Registered Trade Name or Trade Mark of the PPP
• Address of PPP (referred to in 22.1 and 22.3)
• UDI carrier for the procedure pack (Annex VI, Part C, 6.3.3)
• An expiration date based on the shortest dated component within the PP, if applicable
• Specific lot number for PP
• Information on the packaging which maintains the sterile condition of a device (‘sterile
packaging’). This refers to the packaging of the individual device(s) in the procedure pack,
when they are sterilized, while the pack contains other devices that are not sterilized. Should
the entire pack be sterilized by the PPP then this information (indication of sterile packaging
to be recognised as such) has to go on the packaging of the PP and be identified as a UDI-
PI. Each manufacturer may make a choice regarding the symbol(s) they will use, based on
the packaging configuration.
If the PPP removes the primary packaging of the devices inside, any relevant information necessary
for the handling/storing of the procedure pack and the devices needs to be applied in a visible way
on the PP labeling (i.e. storage conditions, latex etc.) The PPP has to be able to identify in their

2
Also see the HPRA Guidance document SUR-G0015-3 for reference

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 internal procedure through the UDI carrier affixed to the PP the various UDI of the components of
the PP, which have been removed during primary packaging removal.

• A list of the medical device contents/ components goes either in the statement or on the
label or in the accompanying documents.

10. Question: Does the PPP need to put safety and performance information or IFU on their
website? (provisions of Annex I.23)

Answer: No, this is a requirement for manufacturer of the devices only. However, if a device included
within the procedure pack has e-IFU per 207/2012 regulation, then the PPP should make sure the
link to the website of the legal manufacturer is available (either on the device label or in an insert into
the pack or on the PP label).

11. Question: What happens if the PPP performs translation of the labelling material of the
original manufacturer or the PPP makes changes to the packaging of the devices?

Answer: If the PPP translates the device labelling of the original manufacturer into additional Member
State languages, without any changes to content, or changes the outer packaging of a device already
placed on the market without impacting the original condition of the device as described in Article
16.2(a) and 16.2(b), the PPP does not assume the responsibilities of the manufacturer.

If the PPP has an agreement in place with the manufacturer and acts on behalf of the manufacturer,
then they are considered a subcontractor and the repackaging or translation are under the control of
the manufacturer. In this case the PPP does not need to follow Art.16.3 or 16.4.

However, if the PPP does not act on behalf of the manufacturer with an agreement in place, we
suggest that the PPP:
• indicates that they carried out translation/repackaging as per Art.16.3 Translation and
repackaging symbols exist for this purpose.
• fulfils quality system requirements limited to translation/repackaging as per Art.16.3.
• follow Art.16.4.for notification to manufacturer and competent authority.

12. Question: Can the primary packaging of a CE marked component be removed and the
component included in the PP as per Art.22.1 and 22.3.?

Answer: If the PPP wants to remove the primary packaging of a component and put it in the pack
the dialogue with device manufacturer (MNF) is key. The primary packaging, sterile or non-sterile,
may be removed if it is reasonably justified and if approved by the legal manufacturer.

13. (*NEW) Question: does the new MD symbol need to be applied to a PP?

Answer: No, a PP as per MDR Art 22(1) and 22(3) is not a Medical Device on its own but a
combination of individual CE marked devices (they become components of the pack). Also, the PP
(as per Art. 22.1 and 22.3.) does not require a CE mark of its own. Therefore, the MD symbols
shall not be applied on the label or packaging of the PP.

The MD symbol needs to be on the individual devices when the PPP receives them from the
manufacturer. Should the packaging of the individual component be removed and with that the

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 indication that it is a medical device; the PPP shall indicate on the PP’s label or packaging that the
particular component is a medical device. In such a case, the PPP would have to make it clear that
the symbol does not refer to the PP as a whole but to a component within the PP.

3. STERILISATION

14. Question: Can a component of the PP be taken out of its original packaging and
(re)sterilised?

Answer: The PP shall be treated as a device in its own right and shall be subject to the relevant
conformity assessment procedure pursuant to Article 52 & Art 22.4, unless a (re)sterilisation of a
device is permitted or required by its manufacturer.

In case that re-sterilisation is possible, agreement between PPP and manufacturer shall be in place.
Responsibility for putting the components together and ensuring their compatibility lies with the PPP.
The PPP will have to comply with the following:

1) Art. 22.2 (c) the activity of combining devices and, if applicable, other products as a
procedure pack was subject to appropriate methods of internal monitoring, verification and
validation.
2) For Individually packed products (sterile as well as non-sterile) → information on the
packaging that has been removed needs to be transferred to the PP labelling (either IFU of
pack inlay). As per Art. 22.2 (b) ‘’they packaged the procedure pack and supplied relevant
information to users incorporating the information to be supplied by the manufacturers of
the devices or other products which have been put together;’’
3) The product within the PP shall be (re) sterilized according to the sterilization instructions
provided by the manufacturer (Art 22.3). The PPP shall draw up a statement (formal,
documented) to that effect. Alternatively, the manufacturer needs to confirm that the PPP
sterilization parameters conform to those of the manufacturer.
4) PPP shall obtain certification for the sterilisation activities from a NB as per Art. 22 (3)

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 4. VIGILANCE

15. (*NEW) Question: How should an incident with a device in an Article 22 PP be managed?

Does the manufacturer manage this directly with the Competent Authority without going
through the PPP?

Answer: The root cause of the incident may be with the manufacturer’s device itself (manufacturer’s
responsibility), or with the PPP’s assembly of the PP i.e. with its the combination/configuration,
processing/sterilisation etc. of the components of the pack -> then the responsibility lies with the
PPP.

Should the PPP have access to the relevant information, the PPP should actively monitor’
EUDAMED vigilance entries related to utilized devices (once Eudamed is available). It is
recommended that there be a written agreement between the PPP and the manufacturer who
provides devices for inclusion into a PP, regarding how vigilance is being managed. Manufacturer
should inform the PPP of vigilance cases and vice-versa. As the name of the PPP must appear on
the PP, the complaint may be sent to the PPP directly by the customer and not to the manufacturer
of the components.

Note: It is currently not foreseen (at the time of writing of this document) for the PPP to submit
vigilance cases (MIR) to Eudamed; there is no legal basis. The MDCG has, however, discussed a
possibility of creating a basis for this via an MDCG endorsed document. European Commission is
analysing such possibility.

5. EUDAMED & UDI

16. (*NEW) Question: Registration in Eudamed

a) will PPP need to register in Eudamed to obtain an SRN?

b) Does this mean that the whole Article 31 ‘Registration of manufacturer, authorised
representatives and importers’ will also apply?

c) If so, would that include the need to periodically confirm accuracy of the information?

Answers:

As per MDR Art.2 (35), the person referred to in art. 22(1) and 22(3), i.e. the PPP, is considered an
economic operator.

a) Yes, PPP will need the SRN. This point shall be further clarified in the upcoming document
from the EU Commission on how certain MDR provisions will function in the absence of
EUDAMED, this document is expected in Q1-Q2/ 2020.

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 b) Yes, although Article 31; the registration of manufacturers does not identify PPP (this may
have been an unintended omission), a PPP is an Economic Operator per Article 2(35). If the
product is to be registered, then the Economic operators first has to be registered and this is
expressed in the MDCG 2018-3 guidance which outlines that the PPP shall apply for
registration as a PPP and obtain an SRN.
c) This is not a legal obligation for the PPP under the MDR. However, it is considered good
practice that the PPP verifies on a regular basis the accuracy of the information that they had
entered in Eudamed.

Note: the SRN module of Eudamed will be made available on voluntary basis – whether the
information on the PPP and the assigned SRN will stay the same after go live of Eudamed is not
entirely clear for the moment.

17. (*NEW) Question: Do the UDI requirements apply to procedure packs?

Answer: See: MDCG 2018-3 Guidance on UDI for systems and procedure packs (chapter 5):
‘’The Basic UDI-DI shall identify systems or procedure packs having the same group of
components and the same intended purpose (4), regardless of the original components
manufacturers.
System and procedure packs shall be assigned and bear their own UDI (including both UDI-DI and
UDI-PI), in accordance with Annex VI, Part C, points 3.7 and 6.3.1. of the MDR

(4)
This is to prevent that two systems or procedure packs with the same intended purpose, but having one or
more components coming from different manufacturers, would need to be assigned two different Basic UDI-
DIs.’’

a) BUDI: MTE also developed guidance on BUDI in its UDI WG, which can be consulted on the
regulatory e-library here
b) UDI assignment:
Procedure packs shall be assigned and bear their own UDI (including both UDI-DI and UDI-PI), in
accordance with Annex VI, Part C, points 3.7 and 6.3.1. of the MDR. In addition, the procedure pack
UDI carrier shall as a general rule be affixed to the outside of the packaging (Annex VI, Part C, 6.3.3).
The MDR does not specify a date for entry into force of UDI labelling for PP as it does for device
where it is based on the risk category.

MTE believes it is a reasonable to align with the systematic of the risk-based approach
provided in Art. 123(3)/f) to affix the UDI carrier on the PP packaging with the timelines
mentioned there:

• Implantable and Class III: 26 May 2021

• Class IIa and IIb (non-implantable): 26 May 2023
• Class I; 26 May 2025

PP do not have a risk class, but in order to align with the risk-based approach, the whole PP shall
follow the risk class of the component with the highest risk class contained in the PP.

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 6. OBLIGATIONS OF THE PPP

18. Question: What documentation should PPP maintain?

Answer: The Procedure Pack file shall include a description of the procedure pack, its UDI procedure,
the statement as required per article 22 of the EU MDR as well as its supporting evidence.

Procedure Pack file (documentation supporting compliance with MDR Article.22.1 - 22.3)

Procedure Pack file

Details
element
• Overall intended purpose of the PP
• Risk class of PP, determined by highest risk classification of
device contained within (requirement for Eudamed registration)
MDCG 2018-4
• Products/Devices in scope including their
• product reference number
• product name
Procedure Pack content • manufacturer
• intended purpose as defined by its manufacturer
• information on CE marking, including risk classification
and applicable regulation/directive
• manufacturer’s label information and instructions for
use
• procedures used to create PPP label
• Procedure pack label
• Labels for products/devices combined in the procedure pack
(manufacturer’s labels and/or labels created by the PPP)
Labeling of the procedure • Any safety related information from the original devices’
labelling
pack
• Instructions for use for products/devices combined in the
procedure pack (manufacturer’s instructions for use and/or
instructions for use created by the PPP)
• Potentially: implant card and related information
• Bill of material (lists all packaging and labeling items provided
with the procedure pack)
• Packaging specification
• In case of repackaging evidence (justification or testing) that the
Packaging of the repackaging
procedure pack • does not impact the product characteristics
• does not negatively change the packaging specification
like product stability, storage and transport
• the above should be ideally verified with the component
manufacturer(s)

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Mutual compatibility
Process description
combining devices
Procedure pack
sterilization
(where applicable)
EU MDR UDI
Reference:
1) MDCG guidance 2018-
3 and 2018-4
2) definitions/descriptions
and formats of the UDI
core elements for PP:
MDR UDI and device data
sets and UDI device data
dictionary on the
Commission’s website
https://ec.europa.eu/growt
h/sectors/medical-
devices/new-
regulations/eudamed_en
Compatibility statement
for procedure packs
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• if applicable; information on the procedure in place to
support any translation, repackaging or relabeling
activities
The assessment of compatibility is made through examination of
the labelling material and other documentation provided by the
components manufacturer. Additional tests may apply. If
documentation is not available, the PPP has to obtain information
e.g. by interacting with the manufacturer.
Evidence that the activity of combining products/devices as a
procedure pack was subject to appropriate methods of internal
monitoring, verification (potentially risk assessment) and validation.
This evidence may include:
• Specifications
• Process descriptions
• Validations
• Sterilization specification by manufacturer
• Sterilization specification by the PPP
• Sterilization validation by the PPP
• Declaration that the sterilization has been carried out in
accordance with the manufacturer's instructions.
• CE certificate sterilization (conformity assessment route)
(The PPP who sterilizes, for the purpose of placing on the
market, device designed by their manufacturers to be sterilized
before use shall, at his choice, follow an appropriate conformity
assessment route limited to the aspects of the procedure
relating to the obtaining of sterility.)
• SRN of the PPP
• The assigned BUDI-DI and UDI-DI
• UDI procedure for PP
• verification of the placing of the UDI carrier on the PP label
All elements as required per article 22 of the EU MDR to be included
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 Note 1: Devices of the PP that are manufactured outside of the EU – they need to have an Authorised
Representative (AR) in the EU. The PP as such will not have a AR.

Note 2: 22 (1) c: products without a CE mark have to comply with their relevant legislation.

Natural or legal persons which combine CE-marked devices with products listed under (a), (b) and
(c) of Article 22(1) in a manner compatible with their intended use/specified limits of use and place
them on the market as a procedure pack shall draw up a statement according to Article 22 (2).

Timelines for keeping the statement are specified in Article 22 (5).

Though this is not stipulated in the EU MDR, and in a view of ensuring proper activities are done with
regards to Packaging/Labelling, Storage, Traceability and Supplier Control, it is recommended that
the PPP maintains on file for components also the following (non-exhaustive):

• information regarding shelf life limitations

• other relevant EU regulations or directives that apply to the product
• the need to retain the primary packaging (unless considerations regarding sterility are made)
• CE certificate(s) for products
• Declaration of conformity(ies) for the component devices
• Lot number for the products in the procedure pack

It is recommended that the PPP and the manufacturer(s) of the devices, which become part of the
PP, have an agreement covering elements such as but not limited to:

o component manufacturer should inform the PPP in case of changes.

o data allowing traceability of the medical device in the procedure pack
responsibilities and actions in case of non-conforming products, vigilance and Field
Safety Corrective Actions.

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For published document: Procedure Packs and new obligations of procedure packs producers

- Confidential: Strictly personal - The recipient may not share with anyone, including his/her direct colleagues.

- Confidential: For your staff only -
- Confidential: For industry use only -
- Appropriate for external use-
The recipient may share with his/her direct colleagues but not anyone outside the
organisation (including members, in the case of national associations)
The recipient may share with his:her staff and with other medtech
X companies/organisations (including members, in the case of national associations)
The recipient may share with anyone, including individuals not from medtech
companies/organisations, if he/she has a need to do so

For further information on the content of this document, please contact:

Oliver Bisazza
o.bisazza@medtecheurope.org
Director Regulations and Industrial Policy
MedTech Europe

References*:
*For EU legislation please see latest consolidated version. For MedTech Europe documents, in case any links
are broken, please consult the latest version under the Regulatory E-Library.

Medical Devices Regulation EU 2017/745

In vitro Diagnostic medical devices Regulation EU 2017/746
MDCG 2018-3 Guidance on UDI for systems and procedure packs
Definitions/descriptions and formats of the UDI core elements for procedure packs are listed in MDR UDI
and device data sets and in UDI device data dictionary posted on the Commission’s website
https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
HPRA Guide to Placing System and Procedure Packs on the Market

The Medical Devices Regulation (EU) 2017/745 (MDR) contains several provisions
that are capable of being given more than one interpretation. In the preparation of
this series of Questions and Answers, MedTech Europe has used its best efforts to
ensure that the opinions and advice expressed are sound. However, the Association
makes no assertion that those opinions and advice are correct and it accepts no legal
responsibility for them. Specific legal advice should be sought before acting on any of the topics covered.
MedTech Europe reserves the right to change or amend this document at any time without notice in order
to keep the information up to date.

Members are reminded that, while competent authorities and notified bodies may be helpful in providing
views as to the meaning of the MDR, it is ultimately for the courts to interpret legislation.

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