mdcg 2018-3 - fdanews

Medical Devices Medical Devices Coordination Group Document MDCG 2018-3

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MDCG 2018-3

Guidance on UDI for systems and

procedure packs

October 2018

This document has been endorsed by the Medical Device Coordination Group

(MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is

composed of representatives of all Member States and it is chaired by a

representative of the European Commission.

The document is not a European Commission document and it cannot be regarded

as reflecting the official position of the European Commission. Any views expressed

in this document are not legally binding and only the Court of Justice of the European

Union can give binding interpretations of Union law.


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1. Scope

This guidance should be read in conjunction with the Guidance on "Basic UDI-DI and

changes to UDI-DI"1 and the Guidance on "UDI database. Definitions, descriptions

and formats of the UDI core elements"2. The guidance is not intended to be

exhaustive in relation to all UDI obligations associated with systems and procedure

packs. The scope of this guidance is therefore limited to the aspects specifically

addressed below. For UDI-related aspects that are not specifically mentioned in this

guidance, the reader should make reference to the relevant provisions of Medical

Device Regulation (EU) 2017/745 (MDR).

2. Definitions

In accordance with Article 2 of the MDR,

‘procedure pack’ means a combination of products packaged together and placed on

the market with the purpose of being used for a specific medical purpose;

‘system’ means a combination of products, either packaged together or not, which

are intended to be inter- connected or combined to achieve a specific medical

purpose;

“Specific medical purposes” are defined in Article 2(1) of the MDR.

Examples of procedure packs are first aid kits, orthodontic procedure packs and skin

traction kits.

Examples of systems are x-ray systems.

3. Principles of Article 22

3.1 Definition of a System or Procedure Pack Producer

Article 22 of the Medical Device Regulation lays down certain obligations for natural

or legal persons, that combine medical devices bearing a CE marking alone or

together with other products which are not devices and are compliant with the

respective legislation which apply to them, in order to place that combination on the

market as either a system or a procedure pack. That combination is intended to

achieve a specific medical purpose.

1 The Guidance is available at https://ec.europa.eu/docsroom/documents/28667 2 The Guidance is available at https://ec.europa.eu/docsroom/documents/28669

https://ec.europa.eu/docsroom/documents/28667



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For the purpose of this guidance and operations related to EUDAMED, 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".

3.2 Exemption with regard to "system or procedure pack producer"

Based on a request of a client or hospital, a natural or legal person in the supply

chain may make available together different products, including CE marked devices,

which are – in that entire combination – neither placed on the market by that natural

or legal person, nor intended by that natural or legal person to be used together for a

specific medical purpose. Devices made available in the described manner are not

considered as systems or procedure packs in accordance with the relevant

definitions provided in Article 2 of the MDR. In this case, that natural or legal person

is not regarded to be a system or procedure pack producer in accordance with Article

22.1, and is considered to be a distributor as per Article 2(34) of the MDR. It is to be

noted that an importer may also make available devices to a client or hospital, in

such manner.

Example: a distributor supplies, upon request of a client, in one shipment, sterile

tweezers, a sterile needle and surgery gloves.

Under the conditions set in Article 22(4), systems and procedure packs are to be

treated as devices in their own right and the related natural or legal persons shall

assume the obligations incumbent on manufacturers. This specific scenario is out of

the scope of the present guidance. Manufacturers of such devices shall refer to

general guidance on UDI which is available on the DG GROW website3.

4. Registration of systems and procedure packs

The system or procedure pack producer shall apply for registration as a system or

procedure pack producer and obtain an SRN.

Systems and procedure packs shall undergo a UDI registration, as described in

Article 29(2) of the MDR. Before placing on the market a system or procedure pack

pursuant to Article 22(1) and (3), that is not a custom-made device, the system or

procedure pack producer shall assign to the system or procedure pack, in

compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to

the UDI database together with the other core data elements referred to in Part B of

Annex VI related to that system or procedure pack.

3 Guidance adopted by MDCG is available at https://ec.europa.eu/growth/sectors/medical-devices/guidance_en.

https://ec.europa.eu/growth/sectors/medical-devices/guidance_en

https://ec.europa.eu/growth/sectors/medical-devices/guidance_en


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The UDI data elements applicable for systems and procedure packs are listed in the

Annex to this guidance.

5. Specific UDI rules for systems and procedure packs

The Basic UDI-DI shall identify systems or procedure packs having the same group

of components and the same intended purpose4, 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.


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MDCG 2018-4

Annex: UDI database

Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs

October 2018










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In accordance with Article 29(2) and Annex VI, Part B of the MDR, in the case of systems and procedure packs, the system or procedure pack producer shall provide to the UDI database the UDI-DI and all of the following information1:

1. quantity per package configuration (meaning the quantity of systems or procedure packs in a package, whenever applicable)

2. the Basic UDI-DI as referred to in Article 29 (MDR) and any additional UDI-DIs,

2a. Indication of specific medical purpose of the system or procedure pack

3. the manner in which the system or procedure pack is controlled (expiry date or manufacturing date, lot number, serial number),

5. name and address of the system or procedure pack producer (as indicated on the label),

6. the SRN of the system or procedure pack producer

8. The medical device nomenclature code as provided for in Article 26 (MDR)2

9. risk class (to be intended as the highest risk class of the device components of the system or procedure pack),

10. if applicable, name or trade name,

11.A. name or, if applicable, system or procedure pack model associated with the BASIC UDI-DI in the statement drawn in accordance with Article 22.1 of the MDR

11.B. reference or catalogue number, or product number found on the system or procedure pack label or accompanying packaging to identify a system or procedure pack

13. additional product description,

14. if applicable, storage and/or handling conditions of the system or procedure pack (as indicated on the label or in the instructions for use),

15. if applicable, additional trade names of the system/procedure pack,

18. labelled sterile (y/n) (meaning that the system or procedure pack in its entirety is labelled as sterile),

19. need for sterilisation before use (y/n)

22. URL for additional information, such as electronic instructions for use (optional),

23. if applicable, critical warnings or contra-indications

1 Please note that format and definition of all UDI data elements are provided at https://ec.europa.eu/docsroom/documents/28669 2 Applicability of this data element to systems and procedure packs is to be determined at the time of designation of the future EU nomenclature for medical devices (foreseen end of 2018/beginning 2019).



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24. status of the system or procedure pack (on the market, no longer placed on the market, recalled, field safety corrective action initiated).

Whenever a label is referred to, the label of the entire system/procedure pack shall be meant, in accordance with Article 22(5) of Regulation 745/2017.

,


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MDCG 2018-5

UDI Assignment to Medical Device Software

October 2018










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Specific consideration on UDI rules for software

UDI Assignment to Medical Device Software

- Scope of UDI requirements for software

In accordance with Annex VI, Part C of the Medical Device Regulation (EU) 2017/745

(MDR) and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR),

only software which is commercially available on its own as well as software which

constitutes a device in itself shall be subject to UDI requirements.

- Basic UDI-DI

In line with the general Guidance on Basic UDI-DI and changes to UDI-DI1, the Basic

UDI-DI connects software with same intended purpose, risk class and essential

design and manufacturing characteristics.

- Changes to UDI-DI

in accordance with Annex VI Part C, Section 6.5 of the MDR and Section 6.2 of the

IVDR, a new UDI-DI is required whenever there is a modification that changes the

original performance, the safety of the software or the interpretation of data. Such

modifications include new or modified algorithms, database structures, operating

platforms, architecture, user interfaces and new channels for interoperability. Such

changes would be considered “significant.”

The Guidance on Basic UDI-DI and changes to UDI-DI2, defines standard rules on

triggers that entail the creation of a new UDI-DI. It lays down that a new UDI—DI

shall be required whenever there is a change that could lead to misidentification of a

device and/or ambiguity in its traceability. In particular, a new UDI-DI shall be

required in the case of any change of the following device related elements: name or

trade name, device version or model, labelled as single use, packaged sterile, need

for sterilization before use, quantity of devices provided in a package, critical

warnings or contra-indications (e.g. containing latex or DEHP3), CMR4/Endocrine

disruptors, colour, language. Not all those data elements are however applicable to

software.

1 The Guidance is available at https://ec.europa.eu/docsroom/documents/28667 2 The Guidance is available at https://ec.europa.eu/docsroom/documents/28667 3 DEHP stands for Bis(2-ethylhexyl) phthalate 4 CMR stands for carcinogenic, mutagenic, or toxic for reproduction




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It can therefore be concluded that, in the specific case of software,

- Any change of the Basic UDI-DI5

- Any changes which impact the original performance, safety, or the

interpretation of data6

- A change to the name or trade name, version or model number, critical

warnings or contra-indications, user interface language

would require a new UDI-DI.

This is to guarantee the traceability and correct identification of the medical device

software.

- Minor software revisions

In accordance with Annex VI, Part C, point 6.5.4 of the MDR and Annex VI, Part C,

point 6.2.4 of the IVDR, minor software revisions require a new UDI-PI and not a new

UDI-DI. Minor software revisions are generally associated with bug fixes, usability

enhancements that are not for safety purposes, security patches or operating

efficiency. Minor software revisions shall be identified by a defined manufacturer-

specific form of identification.

- Evaluation of changes to software by the manufacturers

As part of their maintenance and post-market surveillance activities, manufacturers

should evaluate the possible impact of any changes to the function of software on the

software’s qualification as medical device software, its classification, its intended

purpose and essential design and manufacturing characteristics, as that could trigger

a new Basic UDI-DI.

Likewise, any changes shall be assessed in defining the need of a new UDI-DI.

UDI Placement Criteria

UDI placement criteria for software are laid down in Annex VI, Part C, point 6.5.4 of

the MDR and Annex VI, Part C, point 6.2.4 of the IVDR. Additional considerations on

this aspect will be provided in future guidance.

5 This is a general rule. As indicated in the Guidance on Basic UDI-DI and changes to UDI-DI (available at https://ec.europa.eu/docsroom/documents/28667), "a UDI-DI shall be associated with one and only one Basic UDI-DI”. 6 Annex VI, Part C, point 6.5.2 of the MDR and Annex VI, Part C, point 6.2.2 of the IVDR

https://ec.europa.eu/docsroom/documents/28667)


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MDCG 2018-6

Clarifications of UDI related responsibilities in

relation to Article 16 of the Medical Device

Regulation (EU) 2017/745 and the

In-Vitro Diagnostic Medical Device

Regulation (EU) 2017/746

October 2018










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Relevant obligations arising from Article 16(1)

Any distributor, importer or other natural or legal person that assumes the obligations

incumbent on manufacturers in accordance with Article 16(1), assumes all the

relevant responsibilities related to UDI, including UDI labelling.

This means that those economic operators must also apply for registration as

Manufacturers, receive a Single Registration Number (SRN), apply for the

appropriate conformity assessment procedure and feed and provide UDI-product

registration.

However, in accordance with the provision of Article 16(1)a, when a distributor or

importer enters into an agreement with a manufacturer whereby the manufacturer is

identified as such on the label, the manufacturer is responsible for meeting the

requirements placed on manufacturers in this Regulation, including the relevant UDI

obligations.

Relevant obligations arising from Article 16(2) to 16(4)

The distributor or importer carrying out the operations in Article 16(2) shall ensure

that:

- the activities mentioned in points (a) and (b) of paragraph 2 are performed by

means and under conditions that in no way compromise the readability of the UDI

carrier and its information identifying the actual device.

- the specific procedures are part of the distributor's or importer’s quality

management system.


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MDCG 2018-7

Provisional considerations regarding language

issues associated with the UDI database

(Annex VI, Part A Section 2 and Part B of the

Medical Device Regulation (EU) 2017/745 (MDR)

and the In-Vitro Diagnostic Medical Device

Regulation (EU) 2017/746 (IVDR))

October 2018










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General principles

In consideration of the following:

- In accordance with Article 28(3) MDR and Article 25(3) IVDR, the core data

elements to be provided to the UDI database shall be accessible to the public,

- Annex VI Part C of the MDR and IVDR on the UDI System requires explicitly in its

section 5.10 that the user interface of the UDI database shall be available in all

official languages of the Union and that the use of free- text fields shall, however, be

minimized in order to reduce translations,

- one of the main declared purposes of the European database on medical devices

(Eudamed) as per Recitals 43-46 and Article 33(1a) of the MDR and Recitals 40-43

of the IVDR is to enable the public (including the healthcare professionals) to be

adequately informed about devices placed on the market,

it is essential that the information in the UDI database is publicly available and easily

understandable by any European citizen.

Use of free-text and translation

Among the UDI core data elements of Part B of Annex VI of the MDR and IVDR, only

three data elements ("Additional product description", "Storage and handling

conditions" and "Critical warnings or contra-indications") are expected to have a free-

text format, while a fourth data element (nomenclature term) is associated with a text

allowing to understand the meaning of the associated code (description).

As to the nomenclature, ideally, all the terms/description associated with the

nomenclature codes should be translated in the different Union official languages.

However, it could be also considered having terms available only in English,

particularly taking into account that the nomenclature will have a code. Appropriate

budget and legal verifications will be made on this matter, in the context of the

designation procedure for the new nomenclature.

Among the three data elements that use free-text, one is an optional field: "Additional

product description". It should be provided in English as well as in the languages of

those countries where the device is made available. A data field will be available for

each relevant language.

For the data elements "Storage and handling conditions" and "Critical warnings or

contra-indications", relevant information (as per Annex I Section 23.2 of the MDR and

Annex I Section 20.2 of the IVDR: (k) "any special storage and/or handling

conditions" and (m) "warning or precautions to be taken") should be provided in


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English as well as in the languages of those countries where the device is made

available. It shall be noted that, as laid down in the provisional guidance related to

formats and definitions of UDI data elements, only storage/handling conditions and

critical warnings or contra-indications, that are required to be on the label, shall be

transmitted to the UDI database. With respect to those two data elements, the

possibility to use (in EUDAMED) – as an alternative option - symbols and/or list of

reference that can categorise and provide enough information understandable by

anyone is currently being explored.

Indication of hazardous substances (only applicable for MDR)

For CMR substances, the Commission intends to explore the feasibility for

EUDAMED to provide the list of official CMR1 substances (from CLP Regulation2)

available in the ECHA3 database. The CAS number4, EC number and/or official

chemical name could be used to identify those substances.

With regard to endocrine disruptor substances, pending verification that an official

database managed by the Commission containing these substances is available, a

solution is currently being explored.

Information to be provided is known by the economic operator in charge of the

submission as it shall be displayed on the device label (Annex I Section 23.2 (f) of the

MDR).

1 CMR stands for carcinogenic, mutagenic, or toxic for reproduction 2 Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the 'CLP Regulation') 3 The European Chemicals Agency 4 A CAS Registry Number, also referred to as CASRN or CAS Number, is a unique numerical identifier assigned by the Chemical Abstracts Service (CAS) to every chemical substance described in the open scientific literature

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