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


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 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.

(c) Identifying and analyzing emergent risks on the basis of factual evidence.

(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.

(c) A rationale for the appropriateness of the methods and procedures referred to in points (a) and (b).

(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.


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


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Sunday, September 26, 2021

EU MDR Information on the Label

 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 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 Information on the Label.


Let’s discuss in detail about the Information to be present on the Label as per EU MDR 2017/745.


NOTE: The Highlighted area represents the additional requirements of EU MDR 2017/745 in comparison with MDD 93/42/EEC.


INFORMATION ON THE LABEL


In EU MDR 2017/745, Annex 1, Chapter III, Section 23.2 talks about the requirements for Information on the Label.


The label shall bear all of the following particulars:


1. The name or trade name of the device.

2. The details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device.

3. The name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business.

4. If the manufacturer has its registered place of business outside the Union, the name of the authorized representative and address of the registered place of business of the authorized representative.

5. Where applicable, an indication that the device contains or incorporates: — a medicinal substance, including a human blood or plasma derivative, or — tissues or cells, or their derivatives, of human origin, or — tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012.

6. where applicable, information labelled in accordance with Section 10.4.5.

7. The lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate.

8. The UDI carrier referred to in Article 27(4) and Part C of Annex VII.

9. An unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant.

10. Where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable.



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11. An indication of any special storage and/or handling condition that applies.

12. If the device is supplied sterile, an indication of its sterile state and the sterilization method.

13. Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users.

14. If the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union.

15. If the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles.

16. If the device is custom-made, the words ‘custom-made device.

17. An indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation.

18. In the case of devices that are composed of substances or of 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 by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action.

19. For active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.


Now I hope you have acquired some knowledge about EU MDR 2017/745 requirements for Information on the Label. 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


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If you find this blog post knowledgeable, 

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Friday, September 10, 2021

EU MDR General Safety and Performance Requirement

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 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 General Safety and Performance Requirements.


Let’s discuss in detail about General Safety and Performance Requirements.


GENERAL SAFETY AND PERFORMANCE

REQUIREMENTS


IN EU MDR 2017/745, Annex I talk about General Safety and Performance Requirement.


The compliance with Essential Requirements is important to establish conformity with Medical Device Directive (MDD 93/42/EEC). Likewise, the compliance with General Safety and Performance Requirements is important to establish conformity with EU MDR 2017/745.


The General Safety and Performance Requirements are classified as three Chapters as follows.

 

Chapter I – General Requirements

Chapter II - Requirements regarding Design and Manufacture

Chapter III – Requirements regarding the Information Supplied with the Device


Let’s discuss about the requirements of each Chapter.



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Chapter I – General Requirements


This chapter focusses on Clinical safety, Device performance, Risk management, Benefit risk evaluation, Risk reduction and control. The requirements of Chapter I are as following.


1.     Performance and Safety

 

The performance of the device shall align with the intended design of the device.

 

2.     Reduction of Risks

 

Risks shall be reduced as far as possible with negatively affecting the Benefit – Risk Ratio.

 

3.     Risk Management System

 

The device manufacturer shall establish a well-documented risk management system that continues to be updated throughout the life cycle of a device.

 

4.     Risk Control measures and Residual risks

 

Eliminate or reduce risks as far as possible through safe design and manufacture. Take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated. Provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.

 

5.     Risks related to Use

 

Reduce risks related to use errors as far as possible, which includes the risks related to the ergonomic features of the device and the environment in which the device is intended to be used.

 

6.     Device lifetime

 

There shall not be any compromise in the health or safety of a patient, user, or any other person associated with the device during the lifetime of the device.

 

7.     Packaging, transport, storage

 

Devices must be designed, manufactured and packaged in a way that protects them from any damages during transport and storage.

 

8.     Risk benefit ratio

 

All known and foreseeable risks, and any undesirable side-effects, shall be minimized and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.

 

9.     Devices without a medical purpose

 

For devices without a medical purpose, Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons.

 

Chapter II - Requirements regarding Design and

Manufacture


The Chapter II specifies requirements regarding the following.

1.     

      1. Chemical, Physical and Biological properties.

      2. Infection and Microbial Contamination.

      3. Devices incorporating the substances considered to be Medicinal Product.

      4. Devices incorporating materials of Biological Origin.

      5. Construction of Devices & Interaction with their environment.

      6. Devices with Diagnostic & Measuring function.

      7. Protection against Radiation.

      8. Electronic Programmable Systems.

      9. Active devices & devices connected to them.

    10. Particular requirements for active implantable devices.

    11. Protection against Mechanical and Thermal risks.

    12. Protection against the risks posed to the patient or user by devices supplying energy or substances.

   13. Protection against the risks posed by medical devices intended by the manufacturer for use by lay     persons.

 

Chapter III – Requirements regarding the

Information Supplied with the Device


The Chapter III specifies requirements regarding Label and Instruction for Use.


The Requirements are as following.


1. General requirements regarding the information supplied by the manufacturer.

2. Information on the Label.

3. Information on the packaging which maintains the sterile condition of a device (sterile packaging).

4. Information in the Instruction for Use.


Now I hope you have acquired some knowledge about EU MDR 2017/745 General Safety and Performance Requirements. 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


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Sunday, August 29, 2021

EU MDR Technical Documentation - 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 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 Technical Documentation.


Let’s discuss in detail about Technical Documentation.


TECHNICAL DOCUMENTATION


In EU MDR 2017/745, the Annex II explains about Technical Documentation. The Technical Documentation structure in EU MDR 2017/745 has following six sections.

 

1. Device description and specification, including variants and accessories

2. Information to be supplied by the manufacturer.

3. Design and Manufacturing information.

4. General safety and performance requirements.

5. Benefit-risk analysis and risk management.

6. Product verification and validation.

 

We have discussed about the sections one, two & three in our previous blog EU MDR Technical Documentation - Part 1

Let’s discuss in detail about remaining sections.

 


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4. GENERAL SAFETY AND PERFORMANCE

REQUIREMENTS


The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:

a. The general safety and performance requirements that apply to the device and an explanation as to why others do not apply.

b. The method or methods used to demonstrate conformity with each applicable general safety and performance requirement.

c. The harmonised standards, CS or other solutions applied.

d. The precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

 

5. BENEFIT-RISK ANALYSIS AND RISK

MANAGEMENT


The documentation shall contain information on the following:

a. The benefit-risk analysis referred to in Sections 1 and 8 of Annex I.

b. The solutions adopted and the results of the risk management referred to in Section 3 of Annex I.

 

6. PRODUCT VERIFICATION AND

VALIDATION


The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.

 

6.1. PRE-CLINICAL AND CLINICAL DATA


The results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications.

a. Detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:

b. The biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user.

Physical, chemical and microbiological characterization.

Electrical safety and electromagnetic compatibility.

Software verification and validation (describing the software design and development process and evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer).

Stability, including shelf life.

Performance and safety.

Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council ( 1 ) shall be demonstrated.

Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service.

c. The clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV.

d. The PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Technical Documentation. 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, 

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