Identification in the Supply Chain (MDR Article-25)
1. Traceability of Medical Devices
For adequate traceability of medical devices, distributors and importers must cooperate with authorized representatives or manufacturers.
2. Identification Responsibilities of the Economic Operators
As per the period referred in Article 10(8), economic operators shall identify the following given in the list below to the competent authorities:
- An economic operator to whom they have directly supplied the medical device
- A healthcare institution or a healthcare professional to whom they have directly supplied the medical device
- An economic operator who has directly supplied a medical device to them.
Nomenclature of Medical Devices (MDR Article-26)
1. Availability OF Nomenclature of Medical Devices
The Commission’s responsibility is to ensure the availability of an internationally recognized and free of charge nomenclature of medical devices to manufacturers and other legal persons. Whenever practicable, the Commission shall also ensure this nomenclature’s availability to other stakeholders free of charge.
Unique Device Identification System (MDR Article-27)
1. Functions and Constituents of the Unique Device Identification System
Annex VI of EU MDR defines the UDI (Unique Device Identification) System. Except for custom-made and investigation devices, this UDI system shall help in the medical devices’ facilitation and traceability. This UDI system will consist of the following:
- UDI production, which will further comprise of:
o A UDI-DI (Unique Device Identification-Device Identifier), specific to the manufacturer and the device. This UDI-DI shall provide access to the information present in Annex VI’s Part B
o A UDI-PI (Unique Device Identification-Product Identifier), which will identify the unit of device production. It will also identify packaged devices as per the specifications of Annex VI’s Part C, if applicable.
Placement of the UDI on Device
The UDI will either be placed on the device’s label or its packaging.
According to paragraphs 8 and 9 of this article, operators, health institutions, and healthcare professionals shall do UDI’s storage.
Electronic System’s Establishment for UDI Database
By Article 28 of EU MDR, an electronic system shall be established for the UDI database.
2. System for Assignment of UDIs
To operate a system for assignment UDIs, the Commission shall choose single or multiple entities for this purpose. That/those entity/entities shall be liable to fulfill the following criteria:
- That entity must be an organization with a legal personality
- Under EU MDR requirements, the UDI assignment system of that/those entity/entities shall identify a device throughout its distribution and use
- The UDI assignment system of that/those entity/entities must conform to the relevant international standards
- As per the set of predetermined and transparent terms and conditions, that/those entity/entities shall make its/their UDI assignment system accessible to all interested users.
- The entity/entities shall undertake that:
o It will operate its UDI assignment system at least for ten years after designation
o Upon the request of the Member States and the Commission, the entity/entities shall make the information concerning its UDI assignment system accessible to them
o It/they will show compliance to the criteria and terms of designation.
During the selection of issuing entity/entities, the Commission can reduce financial and administrative burdens for economic operators and health institutions. It can do so by ensuring that UDI carriers (defined in Part C of Annex VI) are readable universally, regardless of the system that the entity/entities uses/use.
3. Assignment of UDI to the Device and All Levels of Packaging
Except for a custom-made device, the manufacturer shall assign a UDI on the device and, if applicable, on all higher packaging levels. The manufacturer will do this before he places the device on the market. Also, the manufacturer will create this UDI in compliance with the issuing entity’s rules mentioned above in paragraph 2 of issuing entities.
The manufacturer will submit and transfer the information laid down in Annex VI’s Part B for all the other medical devices (except custom-made or investigational devices) to the UDI database referred to in Article 28 of MDR.
4. Placement of UDI Carriers
A UDI carrier shall be placed on all devices’ labels and packaging of the higher level. Although, these higher levels of packaging shall not include shipping containers.
5. Use of UDI as per Article 87
As per Article 87 of EU MDR, UDI will report any serious incidents along with field safety corrective actions.
6. UDI & EU Declaration of Conformity
UDI-DI, which is defined in Part C of Annex VI, shall appear on the EU Declaration of Conformity, referred to in Article 19 of the EU MDR.
7. List of UDIs Assigned by the Manufacturer
The manufacturer is liable to keep an up-to-date list of all the UDIs he has assigned. He will take this initiative as per the technical documentation referred to in Annex II.
8. Storage of UDI by Economic Operators
The economic operators shall use electronic means for storage of and keeping the UDI of the devices which they have supplied or with which they have been supplied. These devices will belong either to
- Class III implantable devices
- Devices, categories, or groups of devices are determined by a measure given in Bullet 1 of paragraph 11 shown below.
9. Storage of UDI by Health Institutions
Health institutions shall also use electronic means for storage of and keeping the UDI of the devices which they have supplied or with which they have been supplied. These devices will belong to Class III implantable devices.
If these devices do not belong to Class III of implantable devices, the Member States shall encourage or sometimes require these health institutions to use electronic means to store and keep the UDI.
The Member States shall encourage or sometimes require healthcare professionals to use electronic means to store and keep the UDI of the devices with which have been supplied.
10. Delegated Acts as per Article 115
By following Article 115 of EU MDR, the Commission can adopt delegated acts, i.e.
- In the light of technical progress, the Commission can make amendments to the list of information given in Annex VI’s Part B
- In the light of international developments and technical progress, the Commission can make amendments in the UDI field, according to Annex VI.
11. Harmonization in UDI Standards
Through implementing acts, the Commission can specify the detailed arrangements and procedural aspects for the UDI system. While doing so, the Commission will keep the harmonization concerning:
- Devices, categories, or group of devices upon which obligations of Paragraph 8 apply
- Specification of data that will be included in UDI-PI for specific devices and device groups.
The implementing acts mentioned above shall be adopted as per the examination procedure given in Article 114(3).
12. Measures to be Taken During Harmonization Process
During the harmonization process, the commission shall
- Ensure confidentiality and protection of data as mentioned in Articles 109 and 110, respectively
- Take a risk-based approach into account
- Consider the cost-effectiveness of the measures it is taking
- Look into the convergence of UDI systems developed internationally
- Look after the needs of healthcare systems of the Member States
- Look after the compatibility of medical devices with each other
- Take identification systems of other stakeholders into consideration.
Database of UDI (MDR-Article 28)
1. Establishment & Management of UDI Database
After consulting with MDCG, the Commission shall establish and manage a UDI database. This UDI database will be used for validation, collation, and ensuring the availability of the information present in Annex VI’s Part B to the public.
2. Criteria Regarding Inclusion of UDI-PI & Confidential Product Information
Before it designs the UDI database, the Commission shall consider general principles in Section 5, Part C, of Annex VI. The Commission shall develop a UDI database not to include any UDI-PI or any commercially confidential product information.
3. Accessibility of Core Data to the Public
The public will have access to the core data elements defined in Annex VI’s Part B.
4. Provision of Accessibility through UDI Database
The UDI database’s technical design should allow maximum accessibility of all the information (including multi-user access, automatic uploads, and downloads of that information). In this regard, the Commission shall provide technical and administrative support to manufacturers and other UDI database users.
Registration of Devices (MDR Article-29)
1. Assigning a Basic UDI-DI
Before placing the device on the market, the manufacturer shall assign a basic UDI-DI (as defined by Annex VI’s Part C) according to the issuing entity’s rules referred to in Article 27(2). After assigning the UDI-DI to the device, the manufacturer shall provide this UDI-DI to the UDI database and the other core data elements referred to in Annex VI’s Part B. This condition does not apply to custom-made devices.
2. Assigning a UDI-DI to the System or Procedural Pack
According to the issuing entity rules, the natural or legal person shall assign a basic UDI-DI to the system or pursuant pack. This will be done before the device’s placement on the market system or procedural pack [that is under Article 22(1) and (3)]. The natural or legal person shall also provide UDI-DI and the other core data elements referred to in Annex VI’s Part B to the UDI database. This condition does not apply to custom-made devices.
3. Assigning a UDI-DI to the Devices Subjected to Conformity Assessment
Before the manufacturer applies for assessment to a notified body, he will assign a UDI-DI to the devices subjected to conformity assessment as per Article 52(3) and second and third subparagraphs of Article 52(4).
The UDI-DI of the devices referred to in the first subparagraph shall include a reference on their certificate issued by the notified body. That certificate will be according to point (a) of Section 4’s Chapter 1, Annex XII. This certificate shall show conformance to the information present in section 2.2 of Annex VI’s Part A. Once the notified body issues the certificate, the manufacturer will provide the basic UDI-DI to the database and the core data elements given in Annex VI’s Part B. After doing this, the manufacturer can place the device on the market.
4. Verification of the Information Given in EUDAMED
The manufacturer shall enter and verify the information referred to in Section 2 of Annex VI’s Part A. Section 2.2 will be exempted from this case. The manufacturer will keep the information continuously updated if he has already entered it in EUDAMED. This condition does not apply to custom-made devices.
Registration of Economic System by Using Electronic System (MDR Article-30)
1. Establishment & Management of Electronic Systems
After consulting with MDCG, the commission shall establish and manage an electronic system. This electronic system will be used to create the single registration number referred to in Article 31(2) and for gathering and processing the necessary and proportionate information for the manufacturer’s identification. Where applicable, this electronics system shall also be applied for identifying the authorized representative and the importer. Economic operators can provide the information in this economic system according to the details that have been provided in Annex VI’s Section 1, Part A.
2. Maintenance & Introduction of National Provisions
It is Member States’ choice to maintain or introduce national provisions on registration of devices’ distributors. This corresponds to the devices that are available on Member States’ territories.
3. Providing the Information to the Electronic System
Once the manufacturer has placed the device on the market, importers will be liable to verify that the manufacturer or the authorized representative has provided the information given in paragraph 1 into the electronic system. This condition does not imply custom-made devices.
In case the information referred to in Paragraph 1 is not included or is incorrect, the importers shall notify the manufacturers or the authorized representative. Importers shall also make relevant additions to the details of entry/entries.
Registration of Manufacturers, Authorized Representatives, and Importers (MDR Article-31)
1. Submitting to the Electronic System
Before the device’s placement on the market, manufacturers, authorized representatives, and importers shall submit the information referred to in Annex VI’s Section 1, Part A to the electronic system referred to in Article 30. This does not apply to those who have already registered themselves accordingly. If there is the need to involve the notified body in the conformity assessment procedure, the information referred to in Annex VI’s Section 1; Part A shall be included in the electronic system.
2. Single Registration Number (SRN)
After verifying the data entered, the Competent Authority shall obtain an SRN (Single Registration Number) from the electronic system referred to in Article 30. The competent authority shall issue this SRN to the manufacturer, authorized representative, or the importer.
3. Use Of SRN
While applying to a notified body for conformity assessment and accessing EUDAMED to fulfill its obligations under Article 29, the manufacturer shall use the SRN.
4. Updating the Data in the Electronic System
The economic operator shall update the electronic system data referred to in Article 30 if any change occurs to the information within one week.
5. Accuracy of the Data
The economic operator shall confirm the data’s accuracy one year after its submission and continue to do so every second year. In case the economic operator fails to comply with this obligation within six months of the given deadline, a Member State can take appropriate measures against that economic operator.
6. Verification of Confirmed Data
The competent authority shall verify the confirmed data referred to in Annex VI’s Section 1, Part A.
7. Accessibility of Data to the Public
The public shall have access to the data entered into the electronic system referred to in Article 30.
8. Charging a Fee by Competent Authority
In the light of Article 111, the competent authority can charge the manufacturer, authorized representative, or the importer by using data.
Summary of Safety & Clinical Performance (MDR Article-32)
1. Summary of Safety & Clinical Performance
The manufacturer shall draw up a summary of safety and clinical performance for implantable and Class III devices. This condition does not apply to custom-made and investigational devices.
The manufacturer shall write this summary so that its contents are understandable to the intended user. The contents of this summary shall also be understandable by the patient, if relevant. The public will get access to the summary via EUDAMED.
The draft of this summary of safety and clinical performance shall be part of the documentation sell be sent to and submitted by the notified body. This procedure will take place according to Article 52. Once the notified body validates this summary, it shall upload it to EUDAMED. The manufacturer shall mention the areas regarding the availability of summary on the label or instructions of use.
2. Significant Aspects of the Summary
The safety and clinical performance summary shall include the following;
- Device’s and manufacturer’s identification along with the basic UDI-DI and SRN
- Device’s intended purpose, its indications, and contraindications, and target population
- A description of
o any previous generations or variants of the device (if they existed)
o description of the differences.
If relevant, the device will contain
o description of any accessories
o other products of the device that are intended to be used in combination with the device.
- Any possible diagnostic or therapeutic alternatives
- A reference indicating any harmonized standards or CS that have been applied
- Summary of clinical evaluation that is described in Annex XIV, and relevant information regarding post-market clinical-follow up
- Profile and training for users (if any has been suggested)
- Information regarding any residual risks, warnings, and precautions.
3. Form & Presentation of Data Elements
The Commission can implement acts to set out the form and presentation of data elements needed to be included in the summary of safety and clinical performance. The adoption of these implemented acts shall be in the light of the advisory procedure referred to in Article 114(2).
European Database on Medical Devices (MDR Article-33)
1. Purpose of Setting-up EUDAMED
After consulting with the MDCG, the Commission shall set up, maintain, and manage EUDAMED (European Database on Medical Devices). This establishment of EUDAMED shall carry various purposes, which are:
- Informing the public about
o Various devices that are placed on the market
o Corresponding certificates which the Notified Bodies issue
o Relevant economic operators
o Clinical investigations and enabling sponsors of those clinical investigations to comply with Articles 62-80, Article 82, and any acts adopted in correspondence to Article 81.
- Enabling the unique identification of medical devices within the internal market and facilitating their traceability
- Enabling the manufacturers to show compliance with information obligations present in Articles 87-90 or any acts adopted in correspondence to Article 91
- Enabling the Member States’ competent authorities to perform their tasks concerning MDR and increase cooperation among themselves.
2. EUDAMED & Electronic Systems
Following electronic systems shall be included in the EUDAMED:
- Electronic System for Registration of Devices-EU MDR Article 29(4)
- UDI Database-EU MDR Article 28
- Electronic System on Registration of Economic Operators-EU MDR Article 30
- Electronic System on notified Bodies and Certificates-EU MDR Article 57
- Electronic Systems on Clinical Investigations-EU MDR Article 73
- Electronic System on Vigilance and Post-Market Surveillance-EU MDR Article 92
- Electronic System on Market Surveillance-EU MDR Article 100.
3. Import & Export of Data
To allow the import and export of data, the Commission is liable to consider the compatibility of EUDAMED with national databases and web interfaces.
4. Users of EUDAMED
The Commission shall provide technical and administrative support to the users of EUDAMED. These users can enter the data into EUDAMED, and they include:
- Member States
- Notified Bodies
- Economic Operators
5. Accessibility to EUDAMED
Member States and the Commission shall have access to all of the information given in EUDAMED. The information in EUDAMED shall also be accessible to Notified Bodies, economic operators, sponsors, and the public but only within the limitations on the electronic systems mentioned above. The Commission’s responsibility is to ensure that parts of EUDAMED presented to the public are offered in a user-friendly manner and are easy to search.
6. Collection & Processing of Personal Data
Collection and processing of personal data in EUDAMED will be per the EU MDR. EUDAMED shall contain only that personal data which is necessary for the electronic systems mentioned above. This personal data shall be kept to allow the identification of data subjects for periods that do not exceed those described in Article 10(8).
7. Rights of Data Subjects
It is the responsibility of both the Commission and the Member States to:
- Ensure that data subjects can exercise their rights of accessing, rectifying, and objecting to the information in accordance with Regulation (EC) No 45/2001 and Directive 96/46/EC
- Ensure that data subjects can exercise the right to access data that is related to them effectively
- Ensure that data subjects have the right to correct and erase inaccurate and incomplete data
- Ensure that they (the Commission and the Member States) delete or correct any processed data inaccurately or unlawfully. The Commission and the Member States shall ensure to carry out these measures within 60 days after the data subject’s request.
8. Necessary Arrangements for Setting-up & Maintaining EUDAMED
The Commission is responsible for adopting the implementing acts by the examination procedure given in Article 114(3). Using these acts, the Commission shall plan the necessary arrangements required for the setup and maintenance of EUDAMED. THE Commission shall ensure that the system it has developed does not allow to enter the same information twice within the same module or in different modules of the system
9. Commission as the Controller of EUDAMED & ITS Electronic Systems
The Commission shall be considered as the controller of EUDAMED and all of its electronic systems.
EUDAMDED & Its Functionality (MDR Article-34)
1. Designing and Implementation of Functional Requirements of EUDAMED
The Commission shall collaborate with the MDCG to design functional requirements for EUDAMED. The Commission will also plan the implementation of these requirements by 26 May 2018. This plan shall ensure:
- Complete functionality of EUDAMED
- Publication of the notice by The Commission given in paragraph 3 of this section
- Fulfillment of all the requirements and deadlines given in Article 123 of this regulation and Article 113 of Regulation (EU) 2017/746.
2. Compliance of EUDAMED to Functional Specifications
Based on an independent audit report, The Commission shall inform the MDCG that EUDAMED has attained its full functionality. The Commission shall also notify the MDCG that EUDAMED is fulfilling all the requirements given above.
3. Publication of Notice by the Commission
Once The Commission has is satisfied that EUDAMED has met all the requirements given in paragraph 2, it shall consult with the MDCG to publish a notice in the Office Journal of the European Union.
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