MDCG-2024-16_Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain i

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MDCG 2024-16

Manufacturer Information Form

on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro

diagnostic medical devices

(as per Article 10a of Regulation(EU)2024/1860 amending Regulation(EU)20171745 and

Regulation (EU)20171746)

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.

Note:this form should be completed where reporting on individual or several devices of the same manufacturer.For reporting on

several devices,only one form should be completed and see section 6 for further instruction.See also Q.11 and Q.12 of'Q&A

Obligation to inform in case of interruption or discontinuation of supply'.For the purposes of this form,no personal data should be

submitted or collected,including contact details.

1 Administrative information

Name of National Competent Authority(NCA)to which this report is sent

Type of information

Initial information

Additional information(voluntary)*

Follow-up information (voluntary)*

*Please specify modified sections of the form(if additional or follow-up

information):

Date of information

Reference number assigned by the manufacturer (if any)

Reference number assigned by NCA(as applicable)

2 Information on submitter of the report

Status of submitter

◎Manufacturerr

Authorised Representative (if mandated to act on behalf of the manufacturer)

OOther entity (if acting on behalf of the manufacturer)

3 Manufacturer Information

Manufacturer organisation name

Single registration number (iflled here and already EUDAMED registered,please leave following fields in this section 3 open)

Address

Postcode

City

Phone

Fax

E-mail

Country

MDCG 2024-16

4 Authorized Representative Information(if applicable)

Authorised representative organisation name (if mandated to make this report on behalf of the manufacturer)

Single registration number (iflled here and already EUDAMED registered,please leave following fields in this section 4 open)

Address

Postcode

City

Phone

Fax

E-mail

Country

5 Other entity(if applicable)

Organisation (if completing this report on behalf of the manufacturer)

Address

Postcode

City

Phone

Fax

E-mail

Country

MDCG 2024-16

6 Medical device information

Risk class of device

MDD/AIMDD

AIMD Active implant

MDD ClassⅢl

IVDD

IVD Annex I List A

QIVD AnnexII List B

QIVD for self-testing

OIVD general

MDD

Class

IIb

Ila

I sterile

I measuring function

MDR

ClassⅢ

Qclass IIb

Qclass Ila

classI

Class I sterile

Class I reusable surgical instruments

IVDR

Class D

Class c

Class

Class A sterile

Device Identification

Please fill this section when reporting on an individual device.

Where reporting on several devices,complete the 'MDCG 2024-16 Annex-Device Identification Table'.

Reports on several devices should be for the same manufacturer,the same interruption or discontinuation and same

associated reason (See 'reasons'in section 7).

Unique Device Identification (UDI-DI)/EUDAMED ID (if applicable)

Basic UDI-DI/Eudamed-DI (if applicable)

fthe above UDl section is completed and the device is already registered in EUDAMED,please leave the following fields blank

and go to 'Intended use'field.

flling out the following fieldsfor devices without UDI-DI/EUDAMED DI,please complete all mandatory fields

Model

Catalogue/reference number

Nomenclature system(e.g.EMDN)

Nomenclature code

Nomenclature text

Commercial name/brand name /proprietary or common name

Intended use according to the IFU or add IFU in attachment(voluntary)

Class I measuring function

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1MDCG2024-16MDCG2024-16ManufacturerInformationFormonInterruptionorDiscontinuationofSupplyofcertainmedicaldevicesandcertaininvitrodiagnosticmedicaldevices(asperArticle10aofRegulation(EU)2024/1860amendingRegulation(EU)20171745andRegulation(EU)20171746)ThisdocumenthasbeenendorsedbytheMedicalDeviceCoord...

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