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


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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, 

comment & share it with a friend! 



Tuesday, August 10, 2021

EU MDR Technical Documentation - 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 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.

 

Let’s discuss in detail about each section.

 


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1. DEVICE DESCRIPTION AND SPECIFICATION,

INCLUDING VARIANTS AND ACCESSORIES

 

1.1. Device description and specification

 

The product or trade name and a general description of the device including its intended purpose and intended users.

The Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question.

The intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings.

The principles of operation of the device and its mode of action, scientifically demonstrated if necessary.

The rationale for the qualification of the product as a device.

The risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII.

An explanation of any novel features.

A description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device.

A description or complete list of the various configurations/variants of the device that are intended to be made available on the market.

A general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams.

A description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids

The technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.

 

1.2. Reference to previous and similar generations of the device

 

An overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist.

An overview of identified similar devices available on the Union or international markets, where such devices exist.

 

2. INFORMATION TO BE SUPPLIED BY THE

MANUFACTURER

 

The label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold.

The instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.

 

3. DESIGN AND MANUFACTURING INFORMATION

 

Information to allow the design stages applied to the device to be understood.

Complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation.

Identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.


Let's continue with remaining sections in our next blog.


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, 

comment & share it with a friend! 


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.


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!