Acronyms & Abbreviations
This is what the abbreviation MDR stands for.
What is Medical Device Regulation?
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, in subjects or patients, in the context of a clinical investigation, whether or not related to the investigational device.
What is an Adverse Event?
This document systematically and actively documents activities by gathering, recording, and analyzing relevant data on the quality, performance, and safety of the device throughout its entire lifetime.
What is a PMS Plan?
This entity is the conformity assessment body designated in accordance with the EU MDR.
Who is the Notified Body?
These are individual facts, statistics, or items of information that a manufacturer collects from PMCF activities as evidence to support device conformity to the GSPRs.
What is data?
Region of the world MDR is specific to.
What is the EU?
The two general requirements used to evaluate the main benefits and risks associated with devices that are used as intended.
What are safety and performance?
Another name for the PMS Report.
What is the PSUR or Periodic Safety Update Report?
Any measure aimed at achieving the return of a device that has already been made available to the end user.
The results of a PMCF Report are reported and compiled with other data in this final document.
According to the CEP template, this is what the acronym PICO stands for.
What is Population, Intervention, Comparison (also Comparator or Control), Outcome?
This section of the CER critically and objectively assesses opposing qualities of the Subject Device based on the clinical evidence and data.
What is Benefit/Risk Analysis?
PMS data is generated from these two acronyms/abbreviations.
What are CAPAs and FSCAs?
The MDR defines this term as a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the EU MDR
What is CE Marking or CE marking of Conformity
This specific document guides manufacturers in complying with the requirements of the MDR by specifying the methods and procedures set up by the manufacturer, to proactively collect and evaluate clinical data from the use in or on humans of a CE marked medical device.
What is the PMCF Plan?
With respect to Medical Devices, this is what the abbreviation IMDRF stands for.
What is International Medical Device Regulator’s Forum
Identifying pertinent data for clinical evaluation is this stage.
What is Stage 1?
Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
What is a complaint?
In the MDR a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer is referred to as this term.
What is Clinical Evaluation?
This type of PMCF activity is focused on tracking the effectiveness, safety, and value of medical devices by collecting information on patients treated with specific products.
What is a Registry?
This is the correct spelling of the words that make up the abbreviation CE, as in CE mark.
What is Conformité Européenne?
This document required by Annex XIV: 1a provides an overview of the progression from exploratory investigations, such as first-in-man, feasibility, and pilot studies to confirmatory investigations, such as pivotal investigations and a PMCF for the device under evaluation.
What is a CDP or Clinical Development Plan?
Required methods and procedures employed for post-market surveillance can be found in this Annex of the MDR.
What is Annex III or III or 3 or three?
The body that performs the third-party conformity assessment activities including calibration, testing, certification and inspection.
Who is the Conformity Assessment Body?
This type of PMCF methods and procedures includes evaluation of suitable registries or PMCF studies.
What is Specific?