In Vitro Diagnostic Medical Devices (Ch. 9) Flashcards
What are the directive and regulation for IVDs?
Directive: IVDD, Directive 98/79/EC (in effect Dec. 2003)
Regulation: IVDR, Regulation (EU) 2017/746 (in effect May 2022)
What is the definition of an in vitro diagnostic (IVD) medical device, under the IVDD?
In vitro diagnostic (IVD), per IVDD:
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, 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, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state
- concerning a congenital abnormality
- to determine the safety and compatibility with potential recipients
- to monitor therapeutic measures
What are the 4 types of IVDs under the IVDD?
- higher-risk IVDs to diagnose the indications in Annex II list A
- IVDs to diagnose the lower-risk indications in Annex II list B
- self-tests
- all other IVDs diagnosing indications not in either Annex II lists
TRUE/FALSE: Products for general laboratory use are not IVDs.
TRICK QUESTION!
Products for general laboratory use are not IVDs UNLESS they are intended specifically to be used for in vitro diagnostic examination.
- Depends on the INTENDED USE
What is an IVD kit?
Kit:
Consists of more than one component, made available together and intended to be used to perform a specific IVD examination
- Kit must be CE-marked for the intended purpose
What are the differences between the definition of IVD in the IVDD vs. the IVDR?
- The IVDR includes software or system
- used alone or in combination
- includes specimen receptacles
- and also updates the purpose of providing information to include:
- concerning a physiological or pathological process or state
- concerning congenital physical or mental impairments
- concerning the predisposition to a medical condition or disease
- to determine the safety and compatibility with potential recipients
- to predict treatment response or reactions
- to define or monitor therapeutic measures
TRUE/FALSE: An assay intended to be used for forensic purposes is an example of an IVD.
FALSE
An IVD must (1) meet the definition of a medical device, and (2) be used in vitro for the examination of specimens
TRUE/FALSE: A pulse oximeter is an example of an IVD.
FALSE!
An IVD is used for in vitro examination of a specimen derived from the human body, and the human body is never reintroduced into the body
In vivo examinations - not IVD, a diagnostic medical device
TRUE/FALSE: A continuous blood glucose monitoring system with continuous specimen collection is an IVD.
FALSE!
Devices involving invasive contact with the human body to obtain continuous specimen collection are not considered IVDs - instead, diagnostic medical devices.
TRUE/FALSE: An IVD must involved a specimen collected from the human body, that is not reintroduced into the body.
TRUE
What is the definition of specimen receptacle?
Specimen receptacle:
A device, whether utilizing a vacuum system or not, specifically intended by their manufacturers for the PRIMARY containment and PRESERVATIONof specimens derived from the human body for in vitro diagnostics examination
What is the meaning of primary containment?
Refers to the container’s intended use - if it is mainly intended to come into direct contact with the specimen
What is the meaning of preservation of specimen?
Refers to being intended to protect the specimen, i.e. from temperature fluctuations, light, physical breakage, etc.
This must be on the product labelling & have evidence to support this in the tech. doc.
TRUE/FALSE: Other receptacles in which the specimen may be placed at some point during the analytical process are considered specimen receptacles.
FALSE - considered generally laboratory equipment
TRUE/FALSE: Products used to obtain specimens from the human body are usually not IVDs if they are used to transfer a sample from the body rather than primary containment.
TRUE
What is the definition of an accessory to an IVD?
Accessory to an IVD, per IVDR:
An article which, whilst not being itself an IVD medical device, is intended specifically by its manufacturer to be used together with one or several particular IVDs to specifically enable the IVD to be used in accordance with its intended purpose or to specifically and directly assist the medical functionality of the IVD in terms of its intended purpose
Are invasive sampling devices or devices for obtaining specimens directly applied to the human body considered to be IVD accessories?
No - these would be medical devices
Ex. needles, lancets, lancing devices, mouth tubes, swabs, etc.
TRUE/FALSE: IVDs for performance testing are subject to the IVDD/IVDR.
True
TRUE/FALSE: Assays for research-use only are IVDs.
False - these are labeled “research use only” and do not have a clinical application, so they are not medical devices
(no conformity assessment, no CE mark)
Under IVDD, when are “home-brew” tests considered to be in the scope of IVDD?
Home-Brew test, aka in-house developed IVDs: clinical laboratories develop and produce their own reagents
Considered to be in IVDD’s scope when it is used in a professional and commerical contect
What are the requirements for “in-house developed IVDs” under the IVDR?
Per Article 5, in-house developed IVDs have mostly the same requirements as CE-marked IVDs, including tech doc, quality system, DofC-like documentation, PMS/vigilance requirements, and requires a justification of why this need cannot be met with another CE marked IVD
TRUE/FALSE: Under the IVDD, companion diagnostics are generally self-certified.
TRUE
What is the definition of a companion diagnostic, per IVDR?
Companion Diagnostic:
A device which is essential for the safe and effective user of a corresponding medicinal product to:
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product
- identify patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product
Under the MDR, what is the class of companion diagnostics?
Companion Diagnostics = Class C
What are the steps for placing an IVD on the market?
- Define product classification
- Meet Essential Requirements (ERs) / General Safety and Performance Characteristics (GSPRs)
- Quality system
- Vigilance procedures
- Technical documentation
- Technical documentation on post-market surveillance
- Labelling (language requirements)
- Authorized Representative
- Conformity assessment procedure
- DofC
- CE mark device
- Notify CA
What is the importance of the device classification?
Determines the necessary conformity assessment, as well as the involvement of a notified body
What are the 4 risk classes of IVDs under the IVDR?
Class A - lowest risk
Class B
Class C
Class D - highest risk
What are the IVDR risk classes based on?
The GHTS proposed model - Global Harmonization Task Force
What are Class D IVDs intended for?
Class D IVD: (highest risk)
- detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation, or cell administration
- detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation
- determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management
What are Class C IVDs intended for?
Class C IVDs:
- includes self-testing devices
- companion diagnostics
- STDs
- pre-natal screening
- cancer screening or diagnosis
- human genetic testing
- congenital disorder screenings
- monitoring levels of medicinal products
What are Class B IVDs intended for?
Class B IVDs:
- covers all IVDs
- self-testing of pregnancy, fertility, cholesterol levels, glucose, blood levels
What are Class A IVDs intended for?
Class A IVDs: lowest risk
- products for general laboratory use (buffers, culture media, histological stains)
- specimen receptacles
- instruments to be used specifically for IVD procedures
Under IVDR, what IVD classes do not need to be assessed by a notified body, and can self-certify?
Class A IVDs only
most IVDs will require a notified body
What are Common Specifications (CS)?
Common Specifications (CS): 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
How do Common Specifications get adopted?
Under IVDR, the MDCG can adopt them as implementing acts
What is the harmonized standard for quality system requirements?
ISO 13485 - Quality system requirements for medical devices
Under IVDR, what classes of IVDs require technical documentation?
All of them!
What is the STED format?
STED: Summary Technical Documentation format, developed by GHTF
What is the standard for IVD labeling requirements?
ISO 18113:2009:
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
TRUE/FALSE: Under the IVDD, the user information for all IVDs must be provided in the national languages.
FALSE - only required for self-testing devices
For professional use devices, individual Member States can determine the languages required
What is e-labelling?
The IFU can be provided on a website, meeting certain requirements
What is the harmonized standard for labeling symbols?
ISO 15223-1:2021:
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
What new labeling requirements does the EU IVDR introduce?
- UDI
- Additional requirements for labeling/IFU in the Annex I GSPRs
- language requirements for the DofC
What are the basics of the conformity assessment procedures under IVDD?
- Annex II (Lists A & B) products: notified body
- non-Annex II products: self-certify
- self-testing devices: notified body
What are the basics of the conformity assessment procedures under IVDR?
Class B, C, and D - Notified Body
Class A - self-certify
Companion diagnostics, self-tests, and near-patient testing has additional requirements
Under IVDR, which class of device are subject to additional scrutiny by an EU laboratory?
Class D - highest risk!
How are IVDs registered with the CAs?
Under IVDD: CA is notified by manufacturer or AR
Under IVDR: EUDAMED
What are the main changes in the IVDR?
- IVD classification / conformity assessment
- scope of accessories
- “home-brew” / “in-house” tests
- companion diagnostics
- genetic testing
- supply chain controls, labeling, and UDI
- demonstrating clinical validity and utility
- performance evaluation studies - IVD clinical trials
- vigilance reporting
- market surveillance and un-announced audits
- own brand labeling
What are some other regulations/directives that could apply to IVDs?
- REACH
- transport regulations
- WEEE
- RoHS
- LVD and EMC
- Radioactive materials regulations
How does Regulation (EU) 2016/679 on personal data protection apply to IVDs?
use of left-over samples, in relation to performance studies
