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
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
2
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
3
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
MDD
MDD
MDD
MDD
Class
Class
Class
Class
Class
IIb
Ila
l
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
B
A
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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作者：冒牌货
分类：专业资料
价格：50质量币
属性：5 页
大小：189.49KB
格式：PDF
时间：2026-01-09
