Tuesday, November 30, 2021

EU MDR Classification Rules

 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 Unique Device Identification - Part 1 


EU MDR Unique Device Identification - Part 2


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 Medical Device Classification.


Let’s discuss in detail about the Classification Rules as per EU MDR 2017/745.


EU MDR MEDICAL DEVICE

CLASSIFICATION


In EU MDR 2017/745, Annex VIII Classification Rules talks about Medical Device Classification. Annex VIII has following chapters.

Chapter 1: Definitions specific to classification rules

Chapter 2: Implementing rules

Chapter 3: Classification rules

 

In EU MDR Medical Device is Classified as following

Class I

Class Is – Products which are delivered Sterile

Class Im – Products which has Measuring Function.

Class Ir – Surgical Instruments which are Reusable

Class IIa

Class IIb

Class III

 

The above-mentioned classification is Based on the Risk of the Device and Classification Rules mentioned in Chapter III of Annex VIII.

 

RISK CLASSIFICATION


For example: If the Risk of the Device is Low, Device will be classified as Class I in consideration with the Classification rules. If the Risk of the Device is High, Device is classified as Class III in consideration with Classification rules. (Risk increases, medical device class also increases & vice versa).

Level of Risk possessed by Medical Device is based on following criteria.

1.    Intended Use.

2.    Duration of Use.

Transient Use: Normally intended for continuous use of less than 60 minutes.

Short Term Use: Normally intended for continuous use of 60 minutes – 30 days.

Long Term Use: Normally intended for continuous use of more than 30 days.

3.    Patient Exposure.

4.    Type of Device.

5.    Invasiveness. 

6.    Based on the Severity of harm.

 


Image courtesy: Wikipedia
Licensed under: CC Share Alike


CLASSIFICATION RULES


The Classification Rules are grouped into four.

1. Non-Invasive Devices.

    Non-Invasive device covers Rule 1 – Rule 4.

2. Invasive Devices.

    Invasive Device covers Rule 5 – Rule 8.

3. Active Devices.

    Active Devices covers Rule 9 – Rule 13.

4. Special Rules

    Special Rules covers Rule 14 – Rule 22.

 

The actual rules are as follows:

Rule 1– Non-invasive devices.

Rule 2 – Non-invasive devices intended for channeling or storing (including cells).

Rule 3 – Non-invasive devices that modify biological or chemical composition of blood, body liquids, other liquids and cells.

Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane.

Rule 5 – Devices invasive in body orifices.

Rule 6 – Surgically invasive devices for transient/impermanent use.

Rule 7 – Surgically invasive devices for short term use.

Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc).

Rule 9 – Active therapeutic devices intended to exchange or administer energy.

Rule 10 – Active devices for diagnosis and monitoring that emit ionizing radiation.

Rule 11 – Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes (from class I to class III).

Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances.

Rule 13 – All other active devices.

Rule 14 – Devices incorporating a medicinal substance including human blood or plasma

Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases

Rule 16 – Specific disinfecting, cleaning, and rinsing devices

Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation

Rule 18 – Devices utilising non-viable tissues or cells of human origin or tissues of animal or derivatives

Rule 19 – Devices incorporating or consisting of nanomaterial

Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation

Rule 21 – Substances or combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed

Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management


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


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend! 



Tuesday, November 9, 2021

EU MDR Unique Device Identification - Part 2

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 Unique Device Identification - Part 1 


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 related to Specific device types


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


UNIQUE DEVICE IDENTIFICATION

In EU MDR 2017/745, Annex VI, Part C The UDI System, Section 6 talks about rules for specific device types.

Rules for specific device types


1. Implantable devices:


1.1. Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI)

1.2. The UDI-PI shall have at least the following characteristics:

(a) The serial number for active implantable devices.

(b) The serial number or lot number for other implantable devices.

1.3. The UDI of the implantable device shall be identifiable prior to implantation.

 

2. Reusable devices requiring cleaning, disinfection, sterilization

or refurbishing between uses


2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.

2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.



Image courtesy: Wikipedia
Licensed under: CC Share Alike


3. Systems and procedure packs as referred to in Article 22


3.1. The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI

3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.

3.3. Placement of the UDI carrier on systems or procedure packs

(a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.

(b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.

 

4. Configurable devices


4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.

4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.

4.3. A configurable device UDI-PI shall be assigned to each individual configurable device.

4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.

4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.

 

5. Device Software


5.1. UDI assignment Criteria The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement. The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.

5.2. A new UDI-DI shall be required whenever there is a modification that changes:

(a) The original performance.

(b) The safety or the intended use of the software.

(c) Interpretation of data. Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI. Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency. Minor software revisions shall be identified by a manufacturer-specific form of identification.

5.4. UDI placement criteria for software

(a) Where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software.

(b) The UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an ‘about’ file, or included on the start-up screen.

(c) software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API).

(d) only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.

(e) the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.


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


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend! 



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. 


Image courtesy: Wikipedia
Licensed under: CC Share Alike

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,

(c) labelled as single use,

(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.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend!