Document Number C1063 Rev.

Effective Date 18-MAY-2023 Page 1 of 4

Title: Device Registry for Europe and EUDAMED

1.0 PURPOSE
1.1 The purpose of this procedure is to define what is required for device registrations for
Europe, and the required information for the European database on medical devices,
EUDAMED.
2.0 SCOPE
2.1 This procedure is applicable to all devices, procedure packs/kits distributed in the European
Union (EU) and the information that has to be submitted to EUDAMED.
3.0 REFERENCE DOCUMENTS
3.1 EU 2017/745 Medical Device Regulation; Articles 22, 24, 26, 27, 29, 30, 31, 33
4.0 DEFINITIONS
4.1 EUDAMED: Integrates different electronic systems to collate and process information
regarding devices on the market and the relevant economic operators, certain aspects of
conformity assessment, Notified Bodies (NB), certificates, clinical investigations, vigilance
and market surveillance. The objectives of the database are to enhance overall
transparency, including through better access to information for the public and healthcare
professionals, to avoid multiple reporting requirements, to enhance coordination between
Member States and to streamline and facilitate the flow of information between economic
operators, NB or sponsors and Member States as well as between Member States among
themselves and with the Commission.
4.2 Periodic Safety Update Report (PSUR): A report that contains the following:
4.2.1 Summary of the Post Market Surveillance and Post Market Surveillance Clinical
Follow Up,
4.2.2 Data analysis and Conclusions/Result,
4.2.3 CAPA taken,
4.2.4 Results of Risk Analysis/Residual Risks,
4.2.5 Sales volume, Geographical Location, User group.
4.3 Unique Device Identifier (UDI): A unique numeric or alphanumeric code that generally
consists of the following:
4.3.1 Device Identifier (DI): A mandatory, fixed portion of a UDI that identifies the labeler
and the specific version or model of a device.
4.3.2 Production Identifier (PI): A conditional, variable portion of a UDI that identifies, as
applicable, one or more of the following when included on the label of a device:
4.3.2.1 Lot or batch number within which a device was manufactured,
4.3.2.2 Serial number of a specific device,
4.3.2.3 Expiration date of a specific device,
4.3.2.4 Date a specific device was manufactured.
4.4 Single Registration Number (SRN): A unique code that is assigned to manufacturers,
Authorized Representatives (AR) or importers after they registered in EUDAMED.

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 Document Number C1063 Rev. B

Effective Date 18-MAY-2023 Page 2 of 4

Title: Device Registry for Europe and EUDAMED

4.5 Single Identification Number (SIN): A number assigned for clinical studies for a device.
This number will be entered into EUDAMED for locating study information about the device.
4.6 Procedure Pack (Kits): A combination of products (usually from different manufacturers)
packed together and placed on the market to be used for a specific medical purpose. Some
examples of procedure packs include first aid kits, surgical packs for specific procedures,
theater dressing packs, skin traction kits and orthodontic procedure packs.
4.7 Medical Device Systems: Either a combination of products, packaged together or not,
which are intended to be inter-connected or combined to achieve a specific medical purpose.
Some examples of systems include joint replacement systems, orthopedic drill systems,
prosthetic systems and orthotic systems.
4.8 International Medical Device Nomenclature: To facilitate the functioning of the European
database on medical devices (‘EUDAMED’) as referred to in Article 33, the Commission shall
ensure that an internationally recognized medical devices nomenclature is available free of
charge to manufacturers and other natural or legal persons required by this Regulation to
use that nomenclature. The Commission shall also endeavor to ensure that that
nomenclature is available to other stakeholders free of charge, where reasonably
practicable.
4.9 Economic Operator: A manufacturer, an AR, an importer, a distributor or the person
referred to in Article 22(1) and 22(3);
5.0 RESPONSIBILITIES
5.1 Regulatory Affairs is responsible to ensure device and procedure packs/kit submissions are
correct and active along with working with the IT department to secure a proprietary portal for
the information that is needed to be submitted to EUDAMED.
5.2 Young Innovations (YI) is required to keep records up to date and correct.
6.0 PROCEDURE
Note: Before placing any device(s) or procedure packs/kits on the European market, it must be
registered in EUDAMED while using internationally recognized nomenclature for the device being
registered.
6.1 Before placing a device on the market, the manufacturer shall, in accordance with the rules
of the issuing entity referred to in Article 29(2), assign a Basic UDI-DI as defined in Part C of
Annex VI to the device 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 device.
6.2 The assignment of a Basic UDI-DI referred to in paragraph 1 of Article 26 shall be done
before the manufacturer applies to a NB for an assessment.
6.3 Before placing a device on the market, manufacturers, AR and importers shall, in order to
register, submit to the electronic system referred to in Article 31 the information referred to in
Section 1 of Part A of Annex VI, provided that they have not already registered in
accordance with EUDAMED.
6.4 After having verified the data entered pursuant to EUDAMED, the competent authority shall
obtain a Single Registration Number (‘SRN’) from the electronic system referred to in Article
27 and issue it to the manufacturer, the AR or the importer. The manufacturer shall use the
SRN when applying to a NB for conformity assessment and for accessing EUDAMED in
order to fulfil its obligations under Article 29.

For Use By Affiliates of Young Innovations, Inc.

This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
>>THE USER OF A DOCUMENT CONTROLLED BY A REVISION NUMBER IS RESPONSIBLE FOR CHECKING THE
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 Document Number C1063 Rev. B

Effective Date 18-MAY-2023 Page 3 of 4

Title: Device Registry for Europe and EUDAMED

6.5 For all non-EU manufacturers such as YI, our sponsor will request an SRN from the
competent authority of a member state where the AR or Legal Representative is based. The
manufacturer shall use the SRN when applying to a NB for conformity assessment and for
accessing EUDAMED in order to fulfil its obligations under Article 31.
6.6 Competent Authorities appoint a Local User Administrator.
6.7 Local User Administrators appoint and authorize users in EUDAMED.
6.8 YI medical devices and procedure packs/kits will have a UDI-DI or UDI-PI as required by
Part B of Annex VI.
6.9 In addition to the UDI-DI for the device(s), all of the information from Part A of Annex VI is
required to be entered into EUDAMED.
6.9.1 UDI-PI only go into EUDAMED if connected to a field safety corrective action.
6.10 EUDAMED will also hold vigilance cases and field safety corrective actions by case
numbers.
6.11 Use of (free) nomenclature numbers for devices and incidents will also be stored in
EUDAMED for the device.
6.12 CE Certificates will also be housed in EUDAMED along with the NB number.
6.13 The 24 official languages of the EU will be in EUDAMED.
6.14 Competent Authorities and European Commission will have full access.
6.15 Six modules of EUDAMED contain data about the device and a public site.
6.15.1 Actors (Manufacturers, AR, Importers & Sponsors);
6.15.1.1 Distributors can only access the device through the public access site.
6.15.2 Devices/UDI;
6.15.3 Certificates and NB;
6.15.4 Clinical investigations/performance studies;
6.15.5 Vigilance cases (incidents, field safety corrective actions, field safety notices, trend
reports and PSURs);
6.15.6 Market Surveillance;
6.15.7 Public site access.
6.16 Data can be entered manually or from machine to machine.
6.17 Data must be confirmed before it is fully entered into EUDAMED.
6.18 Once finally uploaded and confirmed, data cannot be corrected, except by creating a new
version.
6.19 Entering data via machine to machine:
6.19.1 YI prepares files on their own server then uploads them to EUDAMED.
6.19.2 All steps of data entry, reviewing, and confirming must take place before uploading.
6.19.3 The company’s database needs to be adapted for EUDAMED.

For Use By Affiliates of Young Innovations, Inc.

This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
>>THE USER OF A DOCUMENT CONTROLLED BY A REVISION NUMBER IS RESPONSIBLE FOR CHECKING THE
CURRENT EFFECTIVE DATE AGAINST THE APPROPRIATE MASTER INDEX BEFORE USING THE DOCUMENT<<
 Document Number C1063 Rev. B

Effective Date 18-MAY-2023 Page 4 of 4

Title: Device Registry for Europe and EUDAMED

6.20 If there is changes to the registered information, the information must be updated and
corrected within one week.
6.20.1 Not later than one year after submission of the information in accordance with
EUDAMED, and every second year thereafter, the economic operator shall confirm
the accuracy of the data. In the event of a failure to do so within six months of those
deadlines, any Member State may take appropriate corrective measures within its
territory until that economic operator complies with that obligation.
6.20.2 The Competent Authorities may use the data to charge YI, the AR, or the Importer a
levy fee.
6.20.3 The data entered pursuant to paragraph 1 of Article 28 in the electronic system
referred to in Article 27 shall be accessible to the public free of charge.
7.0 CHANGE HISTORY
Revision DCR # Effective Date Reason(s) for Change
A 969 26-MAY-2021 New Document
B 1105 18-MAY-2023 Corrected references in SOP for MDR requirements

For Use By Affiliates of Young Innovations, Inc.

This document contains proprietary information. It may not be reproduced or disclosed without prior written approval
>>THE USER OF A DOCUMENT CONTROLLED BY A REVISION NUMBER IS RESPONSIBLE FOR CHECKING THE
CURRENT EFFECTIVE DATE AGAINST THE APPROPRIATE MASTER INDEX BEFORE USING THE DOCUMENT<<