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IVDR Acronyms: What Do They Mean?

IVDR Acronyms List - In Alphabetical Order

AIDC - Automatic identification and data capture (related to UDI)
Technology used to automatically capture data, includes barcodes, smart cards, biometrics and RFID.

BRA - Benefit Risk Analysis
The analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer.

CA  - Conformity Assessment / Competent Authority
The process demonstrating whether the requirements of the IVDR relating to a device have been fulfilled.
A governmental body responsible for transposing regulatory requirements into national legislation.


CAPA - Corrective and Preventative Action
A process belonging to a QMS, whereby problems are investigated, and measures put in place to prevent nonconformities, or recurrence of an identified issue.

CE - Conformité Européenne
A CE Marking, or CE Mark, certification must be obtained by manufacturers for product distribution into the European Union (EU) marketplace. CE marks can be self-certified or issued by notified bodies, depending on the device classification. In the cases of IVDs, CE marks indicate compliance with the IVD regulation.

 

CFS - Certificate of Free Sale
A document used in the registration of a device in a non-EU country, intended to demonstrate that a device is compliant with EU requirements and that it is free to be sold on the EU market.


CLP - Classification, Labelling and Packaging [of substances and mixtures]
A regulation ensuring that the hazards presented by chemicals are clearly communicated to users in the European Union via appropriate labelling.


CMR - Carcinogenic, Mutagenic, or Toxic to Reproduction
Substances which are carcinogenic, mutagenic or toxic to reproduction.


CS - Common Specification
A set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.


CPSP - Clinical Performance Study Plan
A document defining the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study, according to Annex XIII, Section 2.3.2 of the IVDR.

 

CPSR - Clinical Performance Study Report
Approved, documented information on the results and conclusions of a clinical performance study, according to the CPSP, including any negative findings.


DoA - Date of Application
The date the regulation enters into force.


DoC - Declaration of Conformity
A document which states that the IVDR requirements have been fulfilled. It must be continuously updated by the manufacturer and must contain, at a minimum, the information set out in Annex IV of the IVDR. 


ECHA - European Chemicals Agency
An EU agency that implements the EU’s chemicals legislation to protect health and the environment. 


EMA - European Medicines Agency
A decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. EMA protects public and animal health in the EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

 

EMDN - European Medical Device Nomenclature
An alphanumeric structure established by the European Commission, and used for registration of devices in Eudamed.


EUAR - European Authorised Representative
Any natural or legal person established within the EU who has received and accepted a written mandate from a manufacturer, located outside the EU, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under IVDR.


EUDAMED - European Database on Medical Devices

The European Database on Medical Devices, or EUDAMED, is a database developed by the European Commission to facilitate compliance with European medical device regulations.

 

FSCA - Field Safety Corrective Action
Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.


FSN - Field Safety Notice
A communication sent by a manufacturer to users or customers in relation to a field safety corrective action.


GSPR - General Safety and Performance Requirements
A set of minimal requirements which all in vitro diagnostic devices must meet where applicable found in Annex I of the In Vitro Diagnostic Device regulation.


GTIN - Global Trade Item Number
The globally unique identification number allocated to identify a trade item.


HRI - Human Readable Interpretation (related to UDI)
A legible interpretation of the data characters encoded in the UDI carrier.

 

IFU - Instructions for Use
The information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.


IMDRF - International Medical Device Regulators Forum
A voluntary group established in October 2011, IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of its predecessor, the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.


IVD - In Vitro Diagnostic Device
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.


IVDR - In Vitro Diagnostic Device Regulation
Regulation (EU) 2017/746 is an EU Regulation aimed at ensuring the safety and performance on in vitro diagnostic medical devices on the EU market.


MDCG - Medical Device Coordination Group
A group composed of persons designated by the Member States based on their role and expertise in the field of in vitro diagnostic devices and/or medical devices, established to fulfil the tasks conferred on it by IVDR and by Regulation (EU) 2017/745 of the European Parliament and of the Council, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of the Regulations.


NB - Notified Body
A notified body is a conformity assessment body designated in accordance with an applicable regulation.


PEP - Performance Evaluation Plan
A document which specifies the characteristics and the performance of the device and the process and criteria applied to generate the necessary clinical evidence. At a minimum it should include the elements of Annex XIII, Part A, Section 1.1 of the IVDR.

 

PER - Performance Evaluation Report
An overall report including the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports allowing demonstration of the clinical evidence.


PMS - Post-Market Surveillance
All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.


PMPF - Post-Market Performance Follow-Up
A continuous process that updates the performance evaluation.

 

PMSP - Post-Market Surveillance Plan
A systematic plan of the processes that are put in place to ensure the continued safety and performance of a product after it has been released to the market.


PMSR - Post-Market Surveillance Report
A report that is required for class A and B devices summarising the results and conclusions of the post-market surveillance data gathered via the activities outlined in the post-market surveillance plan.


PRRC - Person Responsible for Regulatory Compliance
A person, or people, appointed by a manufacturer or authorised representative responsible for ensuring that the applicable regulatory requirements of the regulation are met.


PSR - Periodic Summary Reports
Used for serious incidents occurring with the same device or device types, as an alternative to individual serious incident reports. This option can only used when certain criteria is met, and on agreement with the applicable competent authorities. 

 

PSUR - Periodic Safety Update Report
A summary of the results and conclusions of the analyses of the post-market surveillance data for class C and D devices gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken.


QA - Quality Assurance
A systematic process that ensures that a product meets their predefined standards.


QMS - Quality Management System
A system that formally documents any procedures, processes, records, and responsibilities that a company puts in place to ensure that their quality policies and objectives are achieved, and continuously monitored and improved upon where possible.


RA - Regulatory Affairs
A profession/department responsible for ensuring that compliance to applicable regulations, directives, and standards is achieved by a company within a regulated industry.


RBA - Risk Benefit Analysis
The analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer.


REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals
A regulation that aims to improve the protection of human health and the environment from the risks that can be posed by chemicals.


RFID - Radio Frequency Identification
A technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.


RMF - Risk Management File
A file made up of any records, files, or documentation produced during a risk management process.

 

SD - Standard Deviation
A measurement of the variation in a set of values.


SDS - Safety Data Sheet
A document containing information on certain substances, the hazards they pose, and any applicable storage or handling instructions.


SIN - Single Identification Number
Eudamed numbers generated for clinical evaluation trial identification.


SOTA - State of the Art
The generally accepted good practice in technology and medicine and not necessarily the most technically advanced solution.


SRN - Single Registration Number
A number issued to a manufacturer, authorised representative, or importer required to access Eudamed to fulfil the applicable economic operator responsibilities.


SSP - Summary of Safety and Performance
A publicly available document required for class C and D devices, intended to provide information on safety and performance to any intended users.


STED - Summary Technical Documentation
A format by which to present technical documentation, established to encourage harmonisation among different countries.


UDI - Unique Device Identifier
A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.


(B)UDI - (Basic) Unique Device Identifier
The primary identifier of a device model. It is assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in technical documentation, certificates and EU declarations of conformity. A single Basic UDI-DI can connect several devices that share the same risk classification, intended use, and design and manufacturing requirements.


UDI-DI - Unique Device Identifier – Device Identifier
A series of numeric or alphanumeric characters that identifies the labeller and the specific version or model of a device.


UDI-PI - Unique Device Identifier – Production Identifier
A series of numeric or alphanumeric characters that is a variable portion of a UDI, identifying for example, lot/batch/serial numbers, an expiration date, or a manufacturing date.


 

IVDR Acronyms Free Download

To help companies navigate the daunting process of implementing the requirements of the IVD Regulation, we have compiled a glossary of the most commonly used acronyms, terms and definitions.

 

This glossary is not only intended to aid understanding of terms within the regulation itself, but also those which frequently arise in guidance documents, whitepapers, presentations, and other relevant material.

Keep this guide with you anywhere you go, to help you make sense of the regulation when you need it most.

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IVDR Acronyms Free Download