Monday, July 26, 2021

EU MDR Clinical Evaluation


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 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 Clinical Evaluation.


In EU MDR 2017/745 Annex XIV, Part A talks about Clinical Evaluation.


Let’s discuss in detail about Clinical Evaluation.


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CLINICAL EVALUATION


1. To plan, continuously conduct and document a clinical evaluation, manufacturers shall:


(a) establish and update a clinical evaluation plan, which shall include at least the following details


An identification of the general safety and performance requirements that require support from relevant clinical data.

A specification of the intended purpose of the device.

A clear specification of intended target groups with clear indications and contra-indications.

A detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters.

A specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects.

An indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device.

An indication how benefit-risk issues relating to specific components such as use of pharmaceutical, nonviable animal or human tissues, are to be addressed.

A clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria.


(b) identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review.


(c) appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device.


(d) generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues.


(e) analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.

 

2. The clinical evaluation shall be thorough and objective, and take into account both favorable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.


3. A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:


Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements.


Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.


Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.


Considerations of equivalence shall be based on proper scientific justification. It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.


4. The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device. The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question. Both favourable and unfavourable data considered in the clinical evaluation shall be included in the technical documentation.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Clinical Evaluation. 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.


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x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


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12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


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Saturday, July 10, 2021

EU MDR Post Market Surveillance

 

Hi friends!!!


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


EU MDR Assessment Routes


EU MDR Timeline, Annex, Chapter


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 Assessment Routes.

 

Let’s get into the topic.


POST MARKET SURVEILLANCE

 

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in following articles and  Annex III.



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ARTICLE 83

 

The article 83 talks about the Post Market Surveillance System of the manufacturer.


Data gathered by the manufacturer's post-market surveillance system shall in particular be used for following purposes.


1.      To update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I.

2.      To update the design and manufacturing information, the instructions for use and the labelling.

3.      To update the clinical evaluation.

4.      To update the summary of safety and clinical performance referred to in Article 32.

5.      For the identification of needs for preventive, corrective or field safety corrective action.

6.      For the identification of options to improve the usability, performance and safety of the device.

7.      To contribute to the post-market surveillance of other devices.

8.      To detect and report trends in accordance with Article 88.

 

ARTICLE 84

 

 The Post Market Surveillance Plan shall be drawn up in accordance with Article 84.


1.      The Post Market Surveillance Plan shall be drawn up in accordance with article 84 and Part A of Annex III.

 

ARTICLE 85

 

The Post Market Surveillance Report shall be drawn up in accordance with Article 85.


1.      The Manufacturers of Class I Medical Device shall submit the Post Market Surveillance Report based on the results and conclusions of Post Market Surveillance Data.

 

ARTICLE 86

 

The Article 86 talks about the Periodic Safety Update Report.


The Manufacturers of Class IIa, IIb, III Medical Device shall submit the Periodic Safety Update Report based on the results of Post Market Surveillance Data which includes the following.


1. The corrective and preventive action taken.

2. The conclusion of risk-benefit analysis.

3. Volume of sales of the medical device, usage population and its characteristics and also the frequency of usage.


For Class IIa Medical Device, the PSUR shall be updated atleast two years once.

For IIb, III Medical Device, the PSUR shall be updated annually every year.

 

ANNEX III – TECHNICAL

DOCUMENTATION ON POST MARKET

SURVEILLANCE

 

(a) The post-market surveillance plan shall address the collection and utilization of available information which includes the following.


1.  The information concerning serious incidents, including information from PSURs, and field safety corrective actions.

2. The records referring to non-serious incidents and data on any undesirable side-effects and information from trend reporting.

3. The relevant specialist or technical literature, databases and/or registers.

4. The information, including feedbacks and complaints, provided by users, distributors and importers.

5. The publicly available information about similar medical devices.


(b) The post-market surveillance plan shall cover the following.


1.  A proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterization of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market.

2. A effective and appropriate methods and processes to assess the collected data.

3.  A suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I GSPR.

4.  An effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field.

5.  The methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period.

6.  The methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users.

7.  A reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86.

8.  A systematic procedures to identify and initiate appropriate measures including corrective actions.

9.  A effective tools to trace and identify devices for which corrective actions might be necessary.


A PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Post Market Surveillance. 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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Wednesday, June 30, 2021

EU MDR Assessment Routes

Hi friends!!!

 

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 Assessment Routes.

 

Let’s get into the topic.


EU MDR 2017/745 MEDICAL DEVICE

CLASSIFICATION


As per EU MDR 2017/745, the Medical Device is classified as following.

 

1. Class I.

2. Class Is Sterile, Im Measuring function, Ir Reusable.

3. Class IIa.

4. Class IIb.

5. Class III.

 

Each of the above classified device have separate assessment routes.

 

Let’s discuss in detail about assessment routes.



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EU MDR 2017/745 ASSESSMENT ROUTES


Class I


The conformity assessment for Class I Medical Device shall be done based on Article 52, Clause 7. The Article 52, Clause 7 states the following.


Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.

 

Class Is, Im, Ir


The conformity assessment for Class Is, Im, Ir shall also be done based on Article 53, Clause 7. The Article 52, Clause 7 states the following about Class Is, Im, Ir.


If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX QMS along with Technical Documentation set out in Annexes II and III or in Part A of Annex XI Production Quality Assurance along with Technical Documentation set out in Annexes II and III.

 

Class IIa


The conformity assessment for Class IIa Medical Device shall be done based on Article 52, Clause 6. The Article 52, Clause 6 states the following.


Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4, Chapter II of that Annex of at least one representative device for each category of devices.


Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Part A, Section 10 Production Quality Assurance or Part B, Section 18 Product Verification of Annex XI. The assessment of the technical documentation shall apply for at least one representative device for each category of devices.

 

Class IIb


The conformity assessment for Class IIb Medical Device shall be done based on Article 52, Clause 4 and Clause 5. The Article 52, Clause 4 and Clause 5 states the following.

 

Clause 4


Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.


However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.


Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.

 

Clause 5


Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.

 

Class III


The conformity assessment for Class III Medical Device shall be done based on Article 52, Clause 3. The Article 52, Clause 3 states the following.


Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Assessment Routes. 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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Friday, June 11, 2021

EU MDR Timeline, Chapter and Annex

 

Hi friends!!!

 

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.

 

Let’s get into the topic.

 

WHY EU MDR 2017/745?

 

The incidents like PIP Breast implant scandal forced medical device regulators to think about revising the medical device directive. It resulted in the European Union Medical Device Regulation EU MDR 2017/745. 

The European Union adopted the new Medical Device Regulation called EU MDR 2017/745, replacing the two existing directives, the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC. The evolution of technology in the field of healthcare has forced the formation of new medical device regulation. It is also aimed to overcome certain shortcomings in earlier directives.



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WHAT IS EU MDR 2017/745 TIMELINE?

 

EU MDR 2017/745 entered into force on 26 May, 2017.


Beginning date of application for EU MDR 2017/745 is on 26 May, 2021. From this date, new devices entering into the market have to be certified under EU MDR 2017/745. Certificates of devices which are already issued under MDD before this date may remain valid for additional 3 years till May 26, 2024.


From 26 May, 2024 – 25 May, 2025 the MDD Devices which are already placed on the market before may continue to be made available.


Last date for putting devices into market according to MDR is on 26 May, 2025. After this date, all devices placed on the market must be in conformity with the EU MDR 2017/745. The devices certified under the EU MDD can no longer be sold or distributed.

 

WHAT ARE THE CHAPTERS IN EU MDR

2017/745?

 

The following are the chapters in EU MDR 2017/745.

 

Chapter I: Scope and Definitions.

Chapter II: Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement.

Chapter III:  Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices.

Chapter IV: Notified bodies.

Chapter V: Classification and conformity assessment.

Chapter VI: Clinical evaluation and clinical investigations.

Chapter VII: Post-market surveillance, vigilance and market surveillance.

Chapter VIII: Cooperation between Member States, Medical Device Coordination Group, expert laboratories, expert panels and device registrars.

Chapter IX: Confidentiality, data protection, funding and penalties.

Chapter X: Final provisions.

 

WHAT ARE THE ANNEXES OF EU MDR

2017/745?

 

The following are the Annexures of EU MDR 2017/745.

 

ANNEX 1: General safety and performance requirements.

ANNEX II: Technical Documentation.

ANNEX III: Technical Documentation on post market surveillance.

ANNEX IV: EU Declaration of conformity.

ANNEX V: CE Marking of conformity.

ANNEX VI: Information to be supplied with the registration of devices and economic operators in accordance with article 23 and data elements of UDI in accordance with article 22.

ANNEX VII: Minimum requirements to be met by notified body.

ANNEX VIII: Classification criteria.

ANNEX IX: Conformity assessment based on full quality assurance and design examination.

ANNEX X: Conformity assessment based on type examination.

ANNEX XI: Conformity assessment based on production quality assessment.

ANNEX XII: Custom made devices.

ANNEX XIII: Minimum content of certificates issued by a notified body.

ANNEX XIV: Clinical evidence and post market follow up.

ANNEX XV: Clinical Investigations.

ANNEX XVI: Products without intended medical purpose.

ANNEX XVII: Correlation table.


Now I hope you have acquired some knowledge about EU MDR 2017/745 Timeline, Chapter and Annex. 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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