Saturday, February 3, 2024

EU MDR Scrutiny Procedure

Hi friends!!!


In our previous blogs, 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 Classification Rules


EU MDR EUDAMED


EU MDR Economic Operators


EU MDR Chapter & Articles - Part 1


EU MDR Chapter & Articles - Part 2


EU MDR Clinical Investigation


EU MDR 2017/745 is live now. And it is 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. In today's blog, we are going to discuss about Scrutiny Procedure of EU MDR 2017/745. 


Let's get into the topic.


SCRUTINY PROCEDURE

The Scrutiny procedure in EU MDR is intended to improve the overall quality of conformity assessments performed by the notified body for high-risk category devices. The Scrutiny is for additional review & improves transparency in the conformity assessment process.

As per Article 54 & 55, manufacturers of Class III Implantable Devices & Class IIb active devices intended to administer or remove medicinal products are subjected to scrutiny.

Apart from Manufacturers of Medical Devices, Scrutiny also impacts the Notified Bodies, Competent Authority, MDCG & Expert Panel.


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The following are the roles & responsibilities of Manufacturers, Notified Body, Competent Authority, MDCG & Expert Panel:

 

Manufacturer:

The Manufacturer of Medical Device submits the Conformity Assessment documentation & Summary of Safety & Clinical Performance to the Notified Body.

 

Notified Body:

The Notified Body performs conformity assessment of the documentation submitted by the manufacturers of the Medical Device. As per “Article 55, Mechanism for scrutiny of conformity assessments of certain Class III & Class IIb devices”, the Notified Body notifies the competent authority about the certificates it has granted by performing conformity assessment in accordance with Article 54(1). Such notification shall take place via electronic system as referred in Article 57. The notification shall include the following details.

The Summary of Safety and Clinical Performance in accordance with Article 32.

Conformity Assessment report by the notified body.

The Instructions for Use as referred in Section 23.4 of Annex I.

If applicable, scientific opinion of the expert panels as referred in Section 5.1 of Annex IX or Section 6 of Annex X. If the Notified Body decided not to follow the advice from Expert Panel, an appropriate justification shall also be included.

 

Competent Authority:

The Competent Authority determines the need to perform the additional scrutiny of the Notified Bodies Conformity Assessment of Documentation. The Competent Authority makes such decisions in accordance with the following articles.

Article 44: Monitoring & re-assessment of notified bodies

Article 45: Review of notified body assessment of technical documentation and clinical evaluation documentation

Article 46: Change to designations & notifications

Article 47: Challenge to the competence of notified bodies

Article 94: Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

The Competent Authority also coordinates with MDCG, if required.

 

Medical Device Coordination group (MDCG):

The MDCG directs the scrutiny process & coordinates with the expert panel, if required.

 

Expert Panel:

The Expert Panel provides scientific expertise & expert opinion on the conformity assessment. The Expert Panel can advise restrictions to medical indications or intended purpose, can limit the certificate validity, propose updates to PMCF Plans, IFU’s, SSCP.

 

Article 54: Clinical Evaluation consultation procedure for certain

class III and class IIb devices

When performing a conformity assessment of Class III & Class IIb Medical Devices, apart from the procedures specified in “Article 52, Conformity Assessment Procedures”, the notified body can also follow the procedure regarding Clinical Evaluation Consultation as specified in Section 5.1 of Annex IX or Section 6 of Annex X.

The notified body shall notify the competent authority via electronic system as referred in Article 57 of whether the above-mentioned procedure of article 54 is applied or not. The notification shall be accompanied by clinical evaluation assessment report.


Now I hope you have acquired some basic knowledge about Scrutiny Procedure as per EU MDR 2017/745. 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


Check out for the below blogs about IEC 62304 & IEC 60601-1.


IEC 62304 Software Configuration Management & Problem Resolution Process


IEC 62304 Software Maintenance Process


IEC 62304 Software System Testing


IEC 62304 Software Unit Implementation & Integration


IEC 62304 Software Architectural & Detailed Design


IEC 62304 Software Requirements Analysis


IEC 62304 Software Development Planning


IEC  62304 Overview & Definitions


IEC 60601-1 Definitions


IEC 60601-1 Classification of Medical Electrical Equipment


IEC 60601-1 General Requirements for Testing Medical Electrical Equipment


IEC 60601-1 Medical Electrical Systems


IEC 60601-1 Protection against unwanted and excessive radiation hazards


IEC 60601-1 General Requirements


IEC 60601-1 Programmable Electrical Medical Systems 


IEC 60601-1 Hazardous situations and fault condition


IEC 60601-1 Construction of Medical Electrical Equipment


IEC 60601-1 Leakage Currents and Patient Auxiliary Currents


IEC 60601-1 Creepage Distance and Air Clearance


IEC 60601-1 Components and Wiring


IEC 60601-1 Mechanical Hazards Moving Parts


IEC 60601-1 Excessive Temperatures


IEC 60601-1 Markings on the Outside of Medical Electrical Equipment


IEC 60601-1 Markings on the Inside of Medical Electrical Equipment


IEC 60601-1 Instability Hazards


IEC 60601-1 Separation of Parts


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Friday, December 29, 2023

EU MDR Clinical Investigation

Hi friends!!!


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


IEC 62304 Software Configuration Management & Problem Resolution Process


IEC 62304 Software Maintenance Process


IEC 62304 Software System Testing


IEC 62304 Software Unit Implementation & Integration


IEC 62304 Software Architectural & Detailed Design


IEC 62304 Software Requirements Analysis


IEC 62304 Software Development Planning


IEC  62304 Overview & Definitions


IEC 60601-1 Definitions


IEC 60601-1 Classification of Medical Electrical Equipment


IEC 60601-1 General Requirements for Testing Medical Electrical Equipment


IEC 60601-1 Medical Electrical Systems


IEC 60601-1 Protection against unwanted and excessive radiation hazards


IEC 60601-1 General Requirements


IEC 60601-1 Programmable Electrical Medical Systems 


IEC 60601-1 Hazardous situations and fault condition


IEC 60601-1 Construction of Medical Electrical Equipment


IEC 60601-1 Leakage Currents and Patient Auxiliary Currents


IEC 60601-1 Creepage Distance and Air Clearance


IEC 60601-1 Components and Wiring


IEC 60601-1 Mechanical Hazards Moving Parts


IEC 60601-1 Excessive Temperatures


IEC 60601-1 Markings on the Outside of Medical Electrical Equipment


IEC 60601-1 Markings on the Inside of Medical Electrical Equipment


IEC 60601-1 Instability Hazards


IEC 60601-1 Separation of Parts


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 Classification Rules


EU MDR EUDAMED


EU MDR Economic Operators


EU MDR Chapter & Articles - Part 1


EU MDR Chapter & Articles - Part 2


EU MDR 2017/745 is live now. And it is 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. In today's blog, we are going to discuss about Annex XV of EU MDR 2017/745. 


Annex XV of EU MDR 2017/745 addresses the requirements for Clinical Investigations. Let's get into the topic.

 

Clinical Investigation

General Requirements

The Clinical Investigations of medical device shall be performed in accordance with an appropriate plan reflecting the latest scientific and technical knowledge. The plan shall be defined in a way to confirm the medical device manufacturer’s claims regarding the safety, performance and benefit risk aspects of medical devices.

The scientific validity of the Clinical Investigations conclusion shall be guaranteed by including adequate number of observations in the Clinical Investigation.

The Procedures & Research Methodologies used in Clinical Investigation shall be relevant to the medical devise under investigation.

Clinical Investigation shall be conducted in a Clinical Environment which represents the intended normal use of the medical device along with intended target patient population.

The endpoints of Clinical Investigation shall be determined and analyzed using a valid statistical methodology. The endpoints of Clinical Investigation shall address the intended purpose, safety, performance and Clinical benefits of the medical device as defined in the plan.

The Investigators involved in the Clinical Investigation shall be adequately trained with respect to the medical device under investigation. The adequacy of training shall be evaluated by the sponsor of Clinical Investigation.

The Clinical Investigation Report shall be the signed by the investigator and shall include evaluation of all the data collected during the Clinical Investigation, including any negative findings.


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Documentation required for Clinical Investigation

In order to apply for the Clinical Investigation, the Sponsor shall submit the application in accordance with Article 70 of EU MDR 2017/745.

The application shall include duly signed Application Form, Investigator’s Brochure, Clinical Investigation Plan and other documents as per Annex XV of EU MDR 2017/745.

Let’s discuss in details about the requirements of Clinical Investigation Plan.

 

Clinical Investigation Plan

The Clinical Investigation Plan shall have the following information but not limited to:


Information about the Sponsor of Clinical Investigation. For example, Name, Address, contact details of sponsor and if applicable sponsor’s representative. Information about the Principal Investigator in each investigation site and their emergency details. Address of each investigation Sites.

The roles, responsibilities and qualification of all kinds of investigators involved in Clinical investigation shall be mentioned in Clinical Investigation Plan.

Single Identification Number of the Clinical Investigation.

Details about the agreement between the sponsor and the investigation site, and the details on how the Clinical Investigation is financed.

Overall synopsis of the Clinical Investigation shall be provided in the Clinical Investigation Plan. The synopsis shall be in the official union language of the concerned member state.

Objectives and Hypotheses of the Clinical Investigation.

Detailed description of the medical device including its intended use, safety, performance, risks and clinical benefits. Expected outcomes shall also be mentioned in the Clinical Investigation Plan.

Details about the relevance of Clinical Investigation with respect to the state-of-the-art clinical practice.

Information about the Sample Size along the power calculation used for sample size, if applicable. Information on how the data collected during Clinical Investigation will be managed.

Details of Informed Consent Process.

Policies for managing the deviation from Clinical Investigation Pan.

Information about safety reporting, its procedures and timelines including definition of adverse events, serious adverse events and device deficiencies.

Policies regarding the establishment of Clinical Investigation Report and publishing of Clinical Investigation results.

Criteria and procedures for following up with the subjects involved in the Clinical investigation. Details about the arrangements made for taking care of the subjects after their participation in the Clinical Investigation.


Now I hope you have acquired some basic knowledge about Clinical Investigation requirements as per Annex XV of EU MDR 2017/745. 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! 


Thursday, November 30, 2023

IEC 62304 Software Configuration Management & Problem Resolution

Hi friends!!!


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


IEC 62304 Software Maintenance Process


IEC 62304 Software System Testing


IEC 62304 Software Unit Implementation & Integration


IEC 62304 Software Architectural & Detailed Design


IEC 62304 Software Requirements Analysis


IEC 62304 Software Development Planning


IEC  62304 Overview & Definitions


IEC 60601-1 Definitions


IEC 60601-1 Classification of Medical Electrical Equipment


IEC 60601-1 General Requirements for Testing Medical Electrical Equipment


IEC 60601-1 Medical Electrical Systems


IEC 60601-1 Protection against unwanted and excessive radiation hazards


IEC 60601-1 General Requirements


IEC 60601-1 Programmable Electrical Medical Systems 


IEC 60601-1 Hazardous situations and fault condition


IEC 60601-1 Construction of Medical Electrical Equipment


IEC 60601-1 Leakage Currents and Patient Auxiliary Currents


IEC 60601-1 Creepage Distance and Air Clearance


IEC 60601-1 Components and Wiring


IEC 60601-1 Mechanical Hazards Moving Parts


IEC 60601-1 Excessive Temperatures


IEC 60601-1 Markings on the Outside of Medical Electrical Equipment


IEC 60601-1 Markings on the Inside of Medical Electrical Equipment


IEC 60601-1 Instability Hazards


IEC 60601-1 Separation of Parts


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 Classification Rules


EU MDR EUDAMED


EU MDR Economic Operators


EU MDR Chapter & Articles - Part 1


EU MDR Chapter & Articles - Part 2


In today's blog, we are going to discuss about IEC 62304.


IEC 62304 states the requirements for Medical Device Software. Satisfying the requirements of IEC 62304 is an important task in order to ensure the safety of patients and efficacy of software used in treating the patients.


Therefore, it is important for Medical Device QA/RA Professionals to understand about Software Configuration Management & Problem Resolution Process requirements as per Clause 8 & 9 of IEC 62304. 

 

Software Configuration Management Process


Configuration Identification

A scheme for unique identification of configuration item and its version to be controlled shall be established by the manufacturer of the medical device software according to the development and configuration planning.

The configuration items and its versions comprising the software system configuration shall be documented by the manufacturer of medical device software.

The details of the SOUP Configuration items for example title, manufacturer details & unique SOUP designator shall be documented by the manufacturer of the medical device software. The unique SOUP designator can be a version, release date, patch number or an upgrade designation.

These requirements are applicable for Class A, B & C, medical device software.


Change Control 

A configuration items shall be changed by the manufacturer of the medical device software only after the approval of change requests. The Change control process should be followed for making decisions regarding the approval of change requests.

The change shall be implemented as specified in the change requests. Activities that need to be repeated because of change implementation shall be identified and performed by the manufacturer of the medical device software. The implemented change shall be verified by the manufacturer.

The details regarding the dependencies & relationships between change requests, approval of change requests, related problems reports shall be maintained by the manufacturer of the medical device software.

The details regarding the history of controlled configuration items including the system configuration shall also be maintained by the manufacturer of the medical device software.

These requirements are applicable for Class A, B & C, medical device software.

Software Problem Resolution Process

Each problem detected in the medical device software shall be recorded in the problem report by the manufacturer of medical device software. The problem reports shall include information about the criticality of the problem detected in the medical device software & any other information that can help in the problem resolution.

Problems can be discovered before or after the release of medical device software into market. Problems can also be discovered inside or outside of the manufacturer’s organization.

Each problem shall be investigated to identify the root cause & outcome of the investigation shall be documented by the manufacturer of the medical device software. Any actions needed for the resolution of problem can be proceeded via creation of change requests. If there are no actions required, a rationale can be provided.

The above change control steps shall be followed for the approval & implementation of change requests.

All the relevant parties depending upon the situation shall be advised about the existence of the problem by the manufacturer of the medical device software.

Appropriate records for problem reports, their resolution & verification shall be maintained by the manufacturer of the medical device software.

The problem reports shall be analyzed for any trends. The resolution shall be verified by the manufacturer of medical device software with respect to adverse trends, complete implementation of change requests and closure of problem reports.

The relevant test documentation with appropriate details shall be maintained by the manufacturer of medical device software.

These requirements are applicable for Class A, B & C, medical device software.

 

Now I hope you have acquired some basic knowledge about Software Configuration Management & Problem Resolution Process as per Clause 8 & 9 of IEC 62304. 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!