Wednesday, October 27, 2021

EU MDR Unique Device Identification - Part 1

Hi friends!!!

In our previous blog, we have discussed about the following topics.

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

EU MDR Technical Documentation - Part 1

EU MDR Technical Documentation - Part 2

EU MDR General Safety and Performance Requirement

EU MDR Information on the Label

EU MDR Post Market Clinical Follow Up

EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 requirements for Unique Device Identification.

Let’s discuss in detail about the requirements for Unique Device Identification as per EU MDR 2017/745.

UNIQUE DEVICE IDENTIFICATION

In EU MDR 2017/745, Annex VI, Part C talks about the UDI System.

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The UDI

1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.

2. Shipping containers shall be exempted from the requirement in Section 1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.

3. The UDI shall contain two parts: a UDI-DI and a UDI-PI.

4. The UDI-DI shall be unique at each level of device packaging.

5. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.

6. Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.

7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.

8. The manufacturer shall assign the UDI to a device following the relevant coding standard.

9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:

(a) name or trade name,

(b) device version or model,

(d) packaged sterile,

(e) need for sterilization before use,

(f) quantity of devices provided in a package,

(g) critical warnings or contra-indications: e.g. containing latex or DEHP.

10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI.

UDI carrier

1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.

2. In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.

3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.

4. For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.

5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable.

6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.

7. If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.

8. The HRI format shall follow the rules of the UDI code-issuing entity.

9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.

10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:

(a) any type of direct marking would interfere with the safety or performance of the device;

(b) the device cannot be directly marked because it is not technologically feasible.

11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.

12. If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required.

13. In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.

14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.

15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.

Now I hope you have acquired some knowledge about EU MDR 2017/745 requirements for Unique Device Identification. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

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Sunday, October 10, 2021

EU MDR Post Market Clinical Follow Up

Hi friends!!!

In our previous blog, we have discussed about the following topics.

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

EU MDR Technical Documentation - Part 1

EU MDR Technical Documentation - Part 2

EU MDR General Safety and Performance Requirement

EU MDR Information on the Label

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 requirements for Post Market Clinical Follow Up.

Let’s discuss in detail about the Post Market Clinical Follow Up as per EU MDR 2017/745.

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POST MARKET CLINICAL FOLLOW UP

In EU MDR 2017/745, Annex XIV Part B talks about Post Market Clinical Follow up.

PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of Annex XIV and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

POST MARKET CLINICAL FOLLOW UP

PLAN

1. PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.

1.1 The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data as following.

(a) Confirming the safety and performance of the device throughout its expected lifetime.

(b) Identifying previously unknown side-effects and monitoring the identified side-effects and contraindications.

(d) Ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I.

(e) Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

1.2 The PMCF plan shall include at least the following.

(a) The general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data.

(b) The specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies.

(d) A reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I.

(e) The specific objectives to be addressed by the PMCF.

(f) An evaluation of the clinical data relating to equivalent or similar devices.

(g) Reference to any relevant CS, harmonized standards when used by the manufacturer, and relevant guidance on PMCF.

(h) A detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.

2. The manufacturer shall analyze the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.

3. The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.

Now I hope you have acquired some knowledge about EU MDR 2017/745 requirements for Post Market Clinical Follow Up. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.