Copyright © 2019 BSI. All rights reserved

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Copyright © 2020 BSI. All rights reserved

IVDR quotes:Completing the Company Information Form – Device Schedule

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Why do we need a Device Schedule?

A comprehensive Device Schedule will enable the quotation process to be completed more efficiently and reduce the probability that the scope will need to be changed at a later date.

• The legal manufacturer and other sites involved• The devices to be covered• The intended use of those devices• The classification of those devices• The potential grouping of those devices for Technical Documentation sampling (if

applicable)• The competency codes required by the technical and QMS auditors to be assigned • The scope and size of the audit

The Device Schedule provides BSI with the information needed to fully understand the scope of an IVDR application, the information to be included on the certificate, and to ensure BSI also complies with the EU IVDR. The Device Schedule includes:

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Where to locate the Device Schedule

• The IVDR Company Information Form (MDF4201) contains a URL to a blank form on page four

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Where to locate the Device Schedule

• Click the URL to download the Device Schedule as an Excel spreadsheet

• Open the Device Schedule

• Click “Enable Editing”

• File > Save As and rename for your use

You should have an Excel spreadsheet with four tabs, as shown

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Add the full name of the legal manufacturing site here; as you would like it shown on the certificate when issued.

Tab 1 – Overview

Add the full address of the legal manufacturing site here; as you would like it shown on the certificate when issued.

Note: Each certificate can only cover a single entity.

Add the name of the site contact person here.Add the date of submission here.

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Tab 3 – Device Schedule tab

This is the most complex tab, so lets take it column by column.

• Column B – IVDD Certificate number if applicable. If there isn’t one, enter “N/A” in this column.

• Column A – Select the application type from the drop down menu (IVDR or UKCA).

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Tab 3 – Device Schedule tab

• Column C – Product name

Include the name of the product as it will appear on the device labelling and as given in the Technical Documentation.

• Column D – Part Number

Include the part number of the product as it will appear on the device labelling and as given in the Technical Documentation.

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Tab 3 – Device Schedule tab

• Column E – Device Nomenclature Code

This is the device code according to the EMDN coding (previously referred to as CND coding). For the EU IVDR, the code will start with “W” and should include six numbers to enable appropriate categorization. Note: This is only essential for quotation of Class C medical devices; however, it will be required to register all devices later so is worth identifying the code at this stage.

EMDN codes may be obtained from the Italian Ministry of Health website - http://www.salute.gov.it/portale/temi/p2_6.jsp?id=328&area=dispositivi-medici&menu=classificazione

There is also an English translation that can be downloaded as a searchable Excel file. http://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_21_file.xlsx

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Tab 3 – Device Schedule tab

• Column F – Intended Use as per the IFU

Intended Use (= Intended Purpose). A full intended use helps to ensure the device is correctly classified and should follow EU/2017/746 IVDR Annex I part 20.4.1 c guidelines:

(i) what is detected and/or measured, (ii) its function (e.g. screening, monitoring, diagnosis etc.), (iii) the specific information that is intended to be provided, (iv) whether it is automated or not,(v) whether it is qualitative, semi-quantitative or quantitative, (vi) the type of specimen(s) required,(vii) where applicable, the testing population, (viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test.

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Tab 3 – Device Schedule tab

• Column G – All Applicable Classification Rules

EU/2017/746 IVDR Annex VIII provides classification rules for devices, governed by their intended use (purpose). Enter the rules selected to generate the classification of the device stated in Column G. If multiple rules apply, the highest classification will apply; however, all applicable rules should be listed.

URL to EU/2017/746 IVDR - https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN

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Tab 3 – Device Schedule tab

• Column H – ClassificationSelect the chosen classification from the drop down menu, which appears when you click in an available cell in the column:

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Tab 3 – Device Schedule tab

• Column I – Justification for the Classification

Provide a detailed classification rationale to enable a reviewer to understand your selection when considered in combination with the intended use.

This is particularly important if the classification is not obvious.

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Tab 3 – Device Schedule tab

• Column J – IVR Code

Each device must be assigned the single most relevant IVR code* according to the device type. These can be found in the Commission Implementing Regulation (EU) 2017/2185. This code is used to help further classify the device by the notified body.

Code definitions are available on the EUR-Lex website: https://eur-lex.europa.eu/eli/reg_impl/2017/2185/oj*In rare cases more than one IVR code may be applicable; in this case include both and discuss with BSI.

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Tab 3 – Device Schedule tabColumn I – IVR Codes (select one*)Devices for blood groupingIVR Devices intended to be used for blood grouping to ensure the immunological compatibility

of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

IVR 0101 ABO system [A (ABO1), B (ABO2), AB (ABO3)]

IVR 0102 Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]

IVR 0103 Kell system [Kel1 (K)]

IVR 0104 Kidd system [JK1 (Jka), JK2 (Jkb)]IVR 0105 Duffy system [FY1 (Fya), FY2 (Fyb)]IVR Other devices intended to be used for blood groupingIVR 0106 Other devices intended to be used for blood grouping

Devices intended to be used for tissue typingIVR Devices intended to be used for tissue typingIVR 0201 Devices intended to be used for tissue typing to ensure the

immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration (HLA A, B, DR)

IVR 0202 Other devices intended to be used for tissue typing

Devices intended to be used for markers of cancer and non-malignant tumours

IVR Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing

IVR 0301 Devices intended to be used for screening, diagnosis, staging or monitoring of cancer

IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours

Devices for human genetic testingIVR Devices intended to be used for human genetic testing

IVR 0401 Devices intended to be used in screening / confirmation of congenital / inherited disorders

IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis

IVR 0403 Other devices intended to be used for human genetic testing

Devices intended to be used to determine markers of infections / immune statusIVR Devices to be used for the for the screening, confirmation,

identification of infectious agents or determination of immune status

IVR 0501 Devices for pre-natal screening of women in order to determine their immune status towards transmissible agents

IVR 0502 Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration

IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents

IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging

IVR 0505 Devices intended to be used to grow / isolate / identify and handle infectious agents

IVR 0506 Other devices intended to be used to determine markers of infections / immune status

Devices for non-infectious pathologies, physiological markers, and impairments

IVR Devices intended to be used for a specific diseaseIVR 0601 Devices intended to be used for screening / confirmation of

specific disorders / impairments

IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease

IVR 0603 Devices intended to be used for screening, confirmation / determination, or monitoring of allergies and intolerances

IVR 0604 Other devices intended to be used for a specific disease

IVR Devices intended to be used to define or monitor physiological status and therapeutic measures

IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components

IVR 0606 Devices intended to be used for non-infectious disease staging

IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing

IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers

IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures

Devices which are controls without a quantitative or qualitative assigned value

IVR Controls without a quantitative or qualitative assigned valueIVR 0701 Devices which are controls without a quantitative assigned valueIVR 0702 Devices which are controls without a qualitative assigned value

Class A devices in sterile condition

IVR Class A devices in sterile condition

IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746

IVR 0802 Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746

IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746 URL to EUR-Lex website https://eur-lex.europa.eu/eli/reg_impl/2017/2185/oj

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Tab 3 – Device Schedule tab

• Column K – IVP Code

Each device should be assigned one or more, if applicable, IVP codes, which are also available in the Commission Implementing Regulation (EU) 2017/2185.

IVDP IVDR types of examination proceduresIVP 3001 Agglutination tests

IVP 3002 Biochemistry

IVP 3003 Chromatography

IVP 3004 Chromosomal analysis

IVP 3005 Coagulometry

IVP 3006 Flow cytometry

IVP 3007 Immunoassays

IVP 3008 Lysis based assays

IVP 3009 Measurement of radioactivityIVP 3010 Microscopy

IVP 3011 Molecular biological testing including nucleic acid assays and next generation sequencing (NGS)

IVP 3012 Physical chemistry

IVP 3013 Spectroscopy

IVP 3014 Tests of cell function

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Tab 3 – Device Schedule tab

• Column L – IVS Code

If applicable, each device should be assigned one, or more, IVS codes also available in the Commission Implementing Regulation (EU) 2017/2185.

If none are applicable, enter “N/A”

IVS IVDR Specifics

IVS 1001 Devices intended to be used for near patient testing

IVS 1002 Devices intended to be used for self-testing

IVS 1003 Devices intended to be used as companion diagnostics

IVS 1004 Devices manufactured utilising tissues or cells of human origin, or their derivatives

IVS 1005 Devices in sterile condition

IVS 1006 Calibrators (point 1.5 of Annex VIII to regulation (EU) 2017/746)

IVS 1007

Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)

IVS 1008 Instruments, equipment, systems or apparatus

IVS 1009Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures

IVS 1010 Devices incorporating software/utilising software/controlled by software

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Tab 3 – Device Schedule tab

• Column M – IVD Code

Each device should be assigned one or more, if applicable, IVD codes also available in the Commission Implementing Regulation (EU) 2017/2185.

Laboratory and clinical disciplines where the in vitrodiagnostic medical devices can be used (diagnostic use)

IVDD Diagnostic use codes for IVDs

IVD 4001 Bacteriology

IVD 4002 Clinical Chemistry / Biochemistry

IVD 4003 Detection of transmissible agents (without organisms or viruses)

IVD 4004 Genetics

IVD 4005 Haematology / Haemostasis including coagulation disorders

IVD 4006 Histocompatability and Immunogenetics

IVD 4007 Immunohistochemistry/ Histology

IVD 4008 Immunology

IVD 4009 Molecular Biology / Diagnostics

IVD 4010 Mycology

IVD 4011 Parasitology

IVD 4012 Virology

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Tab 3 – Device Schedule tabTab

• Column N – Is this device new to the market?

Enter “yes” or “no”.

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Tab 3 – Device Schedule tab

• Column O – Does the device feature any novel features?

Are any novel materials, technologies or intended uses featured in the device? If not, state “N/A”; if yes, list them here. This helps BSI to ensure the device is assigned to a reviewer with the appropriate skill set.

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Tab 3 – Device Schedule tab

• Column P – Materials

The cells in this column have a drop down menu. Select the appropriate option or over type the cell with an appropriate response.

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Tab 3 – Device Schedule tab

• Column Q – Does the device contain software?

This can be stand-alone or integrated into the device. If yes, specify the classification (A, B or C) according to EN62304

The SOFTWARE SYSTEM is software safety class A if:the SOFTWARE SYSTEM cannot contribute to a HAZARDOUS SITUATION; or the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which does not result in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM.

The SOFTWARE SYSTEM is software safety class B if:the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which results in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM and the resulting possible HARM is non-SERIOUS INJURY.

The SOFTWARE SYSTEM is software safety class C if:the SOFTWARE SYSTEM can contribute to a HAZARDOUS SITUATION which results in unacceptable RISK after consideration of RISK CONTROL measures external to the SOFTWARE SYSTEM and the resulting possible HARM is death or SERIOUS INJURY.

Note: These definitions are provided as guidance only and the current version of EN62304 should be consulted before determining class.

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Tab 3 – Device Schedule tab

• Column R – Does the device include any accessories?

If yes, specify the accessories and indicate if the accessories are sold with the device or separately. If no, state “N/A”.

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Tab 3 – Device Schedule tab

• Column S – Is the product sterile?

Enter “Yes” or “No”.

If “No”, columns T and U can be marked “N/A”.

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Tab 3 – Device Schedule tab

• Column T – Sterilisation Method

If the device is sterile, provide the sterilisation method (e.g. ETO, Gamma irradiation etc.). If not sterile, state “N/A”.

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Tab 3 – Device Schedule tab

• Column U – Location of Sterilisation

If the device is sterile, provide the location of the sterilisation process (e.g. in-house, end-user, subcontractor etc.).

If not sterile, state “N/A”.

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Tab 3 – Device Schedule tab

• Column V – Basic UDI-DI

If it is available, state the Basic UDI-DI here; if not, state “N/A”.

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Tab 3 – Device Schedule tab

• Column W – Date of submission for Technical Documentation

If the Technical Documentation is not complete, indicate here which quarter it is expected to be available.

Note: Only devices with complete Technical Documentation can be assessed for a certification. If Technical Documentation availability will span more than one calendar year, discuss the options with BSI. The scope of the certificate may need to be restricted to those devices where the Technical Documentation is available or it may make sense to delay application until all Technical Documentation is ready.

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Tab 3 – Device Schedule tab

• Column X – Technical Documentation Reference

Please include the name or reference number for the Technical Documentation relating to each device. This helps traceability in cases where multiple devices are listed on the same application.

Note: The final Technical Document reference is not essential; however, please indicate which products will be grouped together into one Technical Document. This will help us understand how many Technical Documentation will be included and help BSI quote more accurately.

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Tab 4 – Sites tab

The name and address for the Legal Manufacturer pull through from tab 1 “Overview” into cells B3 and B4 of Tab 4 “Sites”.

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Tab 4 – Sites tab

Add the activities performed at each site

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Tab 4 – Sites tab

Add the number of employees and shift pattern

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Tab 4 – Sites tab

Add the name and contact details of the primary site

contact you would like BSI to use (phone number, including

country code, and e-mail address)

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Tab 4 – Sites tab

Add the details of any existing certificates held and who

issued them. Please provide copies of any CE Marking, ISO13485, ISO9001 or MDSAP certificates held.

If none, state “N/A”.

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Tab 4 – Sites tab

Add the Single Registration Number of the manufacturer

(if available)

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Tab 4 – Sites tab

If applicable to your business, there are three other types of sites that need to be listed for BSI to fully understand the scope of the application. There may be more than one of each, or none, depending on your business.

Select these as required from the drop down menu.

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Tab 4 – Sites tab

If there are other manufacturing sites, the same detail is needed as for the

legal manufacturing site.

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Tab 4 – Sites tab

If there are Critical Subcontractors, the number of employees, shift, site

contact and Registration Number are not required

A Critical Subcontractor is an organization that performs an outsourced process on behalf of the manufacturer, and where the activity or service is critical to the performance and safety of the device(s) (e.g. sterilisation, packaging, testing of final device, regulatory services etc.).

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Tab 4 – Sites tab

If there are Crucial Suppliers, number of employees, shift, site contact,

Registration Number and copies of certificates are not required

A Crucial Supplier is an organization that supplies a key raw material, or component, the failure of which to meet specified requirements could cause a significant degradation in the safety and performance of the device(s) and which is not subject to verification at the manufacturing site.

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Summary of the Device Schedule (DS)• Complete all cells

• Provide a clear intended use / intended purpose:• Annex I section 20.4.1. (c)

• Carefully select the classification and applicable rules:• EMDN (CND) code – W+6 digits (essential for Class C devices)• One IVR code• Multiple IVP, IVS, IVT codes as applicable

• Consider the date for submission of Technical Documentation

• Include all details of the Legal Manufacturer

• Include the required details of Critical Subcontractors and Crucial Suppliers

A well completed Device Schedule will allow a more efficient quotation process and a more accurate quote.

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Thank you foryour application