Friday, December 29, 2023

EU MDR Clinical Investigation

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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 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.

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