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Customer Number (If Available) : Manufacturer Name:: List of Medical Devices (MDR)

This document is a list of medical devices provided by a manufacturer. For each medical device, the following information is included: product designation and intended purpose, risk class, classification rule, MD codes, EMDN, basic UDI-DI, assignment to technical documentation, information on accessories, details of any outsourced processes, certification status, and conformity assessment procedures. The manufacturer name and contact information is listed at the top, and signatures and application dates are provided at the bottom.

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hitham shehata
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263 views2 pages

Customer Number (If Available) : Manufacturer Name:: List of Medical Devices (MDR)

This document is a list of medical devices provided by a manufacturer. For each medical device, the following information is included: product designation and intended purpose, risk class, classification rule, MD codes, EMDN, basic UDI-DI, assignment to technical documentation, information on accessories, details of any outsourced processes, certification status, and conformity assessment procedures. The manufacturer name and contact information is listed at the top, and signatures and application dates are provided at the bottom.

Uploaded by

hitham shehata
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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List of Medical Devices (MDR)

Customer number (if available):

Manufacturer name:

Product designation & intended purpose Risk class1 Classification MD Codes 2 EMDN 3 Basic UDI-DI Assignment to technical Information on accessories 4 For outsourced processes Certification status of the Conformity assessment
(brief description) (descending rule (Information only required for documentation (unless separately listed) manufacturer's medical devices procedures 7
(product name/article number/type name) order) (with indent) Automated summary! devices of class IIb) (e.g. number, product line or in the sense of the MDR
similar)
Name and address of the Activities / materials / Certification status of the certified applied for not by ANX. IX, ANX. IX, ANX. XI,
supplier(s) components 5 supplier(s) 6 by mdc at mdc mdc Chap. I Chap. II Part A
(attach copies of certificates) [x / ---] [x / ---] [x / ---] [x / ---] [x / ---] [x / ---]

ID: 1489 Page 1 of 2 002/05.2020


List of Medical Devices (MDR)
Product designation & intended purpose Risk class1 Classification MD Codes 2 EMDN 3 Basic UDI-DI Assignment to technical Information on accessories 4 For outsourced processes Certification status of the Conformity assessment
(brief description) (descending rule (Information only required for documentation (unless separately listed) manufacturer's medical devices procedures 7
(product name/article number/type name) order) (with indent) Automated summary! devices of class IIb) (e.g. number, product line or in the sense of the MDR
similar)
Name and address of the Activities / materials / Certification status of the certified applied for not by ANX. IX, ANX. IX, ANX. XI,
supplier(s) components 5 supplier(s) 6 by mdc at mdc mdc Chap. I Chap. II Part A
(attach copies of certificates) [x / ---] [x / ---] [x / ---] [x / ---] [x / ---] [x / ---]

If the available lines are not sufficient, please contact us.

1
Assignment to the classes Is (sterile), Im (with measuring function), Ir (reusable surgical instruments), IIa, IIb and III
2
In accordance with Implementing Regulation (EU) 2017/2185, taking into account the guideline MDCG 2019-14 (Explanatory note on MDR codes). Please fill in all codes (including MDS and MDT codes), that apply to the product, in the right part of the table. Please note that printing of this part of the table is not necessary.
The indication of the MDR codes is necessary to check whether the medical devices are included in the mdc's scope of designation and may be used for sample planning.
3
European Medical Device Nomenclature (EMDN). The EMDN classification code is available on the Eudamed database and is based on the Italian classification code "Classificazione Nazionale Dispositivimedici(CND)". The EMDN is required to assign class llb to generic product groups for sample planning. As long as the EMDN is not yet
available in Eudamed, the CND code (available at http://www.salute.gov.it) must be entered.
4
Including information on risk class, reprocessing / sterilisation procedure and whether the accessories are placed on the market under the company's own name or that of a third party
5
Required information on outsourced processes: Development, manufacturing, cleaning, quality control, sterilisation, packaging, labeling, storage by subcontracted storage or delivery of material/components/finished products (please specify), other (please specify)
6
Please fill in: No certification, ISO 9001, ISO 13485, 93/42/EEC, Regulation 2017/745, Other: (please specify)
7
For products newly applied for: please enter the conformity assessment procedure applied for at mdc

Place, date: Name and signature of the manufacturer: Please fill in only if the list of medical devices is part of the application for certification:
Please fill in the date of the application [YYYY-MM-DD]:

The list of medical devices is part of the application according to Regulation (EU) 2017/745 of:

ID: 1489 Page 2 of 2 002/05.2020

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