EU MDR Procedure for Custom-Made Devices

 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 Scrutiny Procedure

EU MDR Instructions for Use

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 the requirements of Custom-Made Devices as per EU MDR 2017/745. 

Let's get into the topic.

Procedures for Custom-Made Devices

In EU MDR 2017/745, Annex XIII provides the requirements for Custom-Made Devices. Let's discuss about the requirements.

For Custom made devices, the statement containing the following information shall be provided by the manufacturer or authorized representative of the custom-made medical device:

The name and address of the manufacturer and all of their manufacturing sites. If applicable, name and address of the authorized representative shall also be provided.

The name of the person who made the prescription for the custom-made device and who is authorized by the national law based on their professional qualifications to make such prescription. The name of the concerned health institution shall also be provided.

As indicated by the prescription, information about any specific characteristics of the custom-made device shall be provided.

Information that the custom-made device will be exclusively used by a particular patient or a user shall be provided as a statement. The statement shall also identify the name, an acronym or a numerical code.

A statement that the custom-made device in question conforms to Annex I, General Safety and Performance Requirements of EU MDR 2017/745 shall be provided. If applicable, information about any general safety and performance requirements which have not been fully met shall be provided.

If applicable, information that the custom-made device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin, or of animal origin shall be provided.

Any data allowing the identification of the custom-made device in question.

The manufacturer of the custom-made device shall keep available the documentation containing information about their manufacturing sites for the competent authorities. The documentation shall also allow an understanding to be formed regarding the design, manufacture and performance of the custom-made device, including its expected performance, so as to allow the assessment of conformity by the competent authorities with respect to the requirements of EU MDR 2017/745.

The manufacturer of the custom-made device shall take all necessary actions to ensure that their manufacturing process produces devices that are manufactured in accordance with the documentation submitted to the competent authorities.

The statement provided by the manufacturer of the custom-made device as mentioned above shall be kept for a period of atleast 10 years at the disposal of competent authorities after the custom-made device has been placed on the market.

If the custom-made device is an implantable device, the statement provided by the manufacturer shall be kept for a period of atleast 15 years at the disposal of competent authorities after the custom-made device has been placed on the market.

The experience gained during the post-production phase of the custom-made device shall be reviewed and documented by the manufacturer, including from Post Market Clinical Follow-up as referred in Part B of Annex XIV. The manufacturer of the custom-made device shall also implement appropriate means to apply any corrective action.

The manufacturer of the custom-made device shall report to the competent authorities about any serious incident or field safety corrective actions or both as soon as the manufacturer learns about them. The reporting to the competent authority shall be in accordance with Article 87(1), Reporting of serious incidents and field safety corrective actions.

Now I hope you have acquired some basic knowledge about the requirements of custom-made devices 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

EU MDR Instructions for use

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 Scrutiny Procedure

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 the requirements of instructions for use as per EU MDR 2017/745. 

Let's get into the topic.

Instructions for use

In EU MDR 2017/745, Annex I – “General Safety and Performance Requirements”, Chapter III – “Requirements regarding the information supplied with the device”, section 23.4 provides requirements about information in the Instructions for use.

Let’s discuss about few important information’s to be provided in the Instructions for use as per EU MDR 2017/745.

The Instructions for use shall contain the following details, but not limited to the following:

Medical Device’s intended purpose with information about indications, contra-indications, target patient groups, intended users as appropriate.

Information that informs the user and/or patients using the medical device about the warnings, precautions, contra-indications, relevant measures to be taken and limitations in the usage of medical device.

Information about any residual risks, contra-indications & undesirable side effects, including the information to be conveyed to the patient.

If applicable, information allowing healthcare professionals to verify whether the device is suitable for use and to select the corresponding software and accessories. Other information required by the user to use the device appropriately.

Information about requirements with respect to any special facilities and trainings or qualifications of the medical device users and/or other persons.

If applicable, any specifications of the Clinical Benefits to be expected from the medical device and links to the summary of safety and clinical performance. The Performance Characteristics of the device shall also be specified in the Instructions for Use.

Instructions to follow in the event of sterile packaging of the medical device being damaged or unintentionally opened before use. Appropriate instructions for sterilization, if the medical device being supplied is non-sterile with the intention of getting sterilized before use.

Information related to verifying whether the medical device is installed properly and is ready to perform safely, as intended by the manufacturer of medical device.

Image courtesy: Wikipedia

Licensed under: CC Share Alike

If the medical device is intended to be used together with other devices and/or general-purpose equipment’s, such devices shall be identified in the instructions for use to obtain the safe combination. In case if any restrictions to the combinations of device and equipment, it needs to specified in instructions for use.

If the medical device emits radiation for medical purposes, Information about the nature, type and if appropriate, intensity and distributions of the radiation emitted by the medical device shall be provided in the Instructions for Use. Information for protecting the user, patient and other persons from the unintended radiation during the use of medical device shall also be provided

If the medical device is reusable, then information about appropriate processes for reuse shall be specified in the instructions for use. Information shall also be provided to identify when the medical device should not be reused. E.g.: Maximum number of allowable reuses.

If the medical device is single use device, information about the risks that can happen if the device is re-used, shall be captured in the instructions for use.

Information about the warnings or precautions that needs to be taken to facilitate the safe disposal of medical device, it’s accessories and consumables shall be mentioned.

The circumstances in which the lay user needs to consult with healthcare professionals shall be specified, if the medical device is intended to be used by lay users.

Date of issue of the instructions for use shall be specified. If the instruction for use is revised, the revised date and identification of the latest revision shall be specified.

Notice to the user and/or patient shall be provided in the instructions for use, stating that any serious incident with respect to the device should be reported to the manufacturer of the device.

 

Now I hope you have acquired some basic knowledge about the requirements of instructions for use 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

 

 

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.

Image courtesy: Wikipedia

Licensed under: CC Share Alike

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

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! 

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.

Image courtesy: Wikipedia

Licensed under: CC Share Alike

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!