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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
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IEC 62304 Software Requirements Analysis
IEC 62304 Software Development Planning
IEC 62304 Overview & 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
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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
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IEC 60601-1 Separation of Parts
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
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 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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