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A Roadmap to IVDR Compliance for IVD and CDx
new post-market surveillance and vigilance requirements.
The IVDR also calls for establishment of the
European Databank on Medical Devices (EUDAMED),
a comprehensive database containing information
on the lifecycle of all products marketed in the EU,
including six interconnected modules:
1. Actor registration
2. UDI and device registration
3. Notified bodies (NBs) and certificates
4. Clinical investigations and performance studies
5. Vigilance and post-market surveillance
6. Market surveillance
7. Impact of IVD reclassification
Under the In Vitro Diagnostic Directive (IVDD)
published in 1988, the two methods for market entry
were self-certification and notified body (NB) approval.
Approximately 80 percent of IVDs were eligible for
self-certification and NB approval was reserved for
blood banking products, self-testing devices, and IVDs
for certain infectious diseases.
The transition to IVDR is paradigm-shifting for manufacturers
as the regulation outlines a four-class, riskbased
system where risk is based on the probability
and severity of harm.1
IVDR established four risk
classes, where D is the highest risk and A is the lowest.
IVDs classified under List A and B of IVDD now fall into
Class D. If an IVD has multiple uses, all uses must be
classified and the highest risk class is applied. All prodTable
1. Risk Classes Under IVDR2
Class
Description
D Covers general life-threatening conditions and, more specifically, transmissible agents in blood or other biological materials
intended to be transplanted or re-administered into the body
C
B
A
Covers a diverse mix of high-risk IVDs that present a lesser risk to the wider population. This class also covers most self-testing
IVDs and testing for infectious diseases and cancer, companion diagnostics, and genetic screening.
Covers all IVDs not covered specifically in other classification rules as a default class. This class also covers self-testing IVDs
for pregnancy and fertility testing, detection of cholesterol levels, and detection of glucose, erythrocytes, leukocytes, and
bacteria in urine.
Covers laboratory devices, instruments, and specimen receptacles
20 | GENengnews.com
ucts other than Class A products require pre-market
review by an NB. In addition, Class A devices that
include sterile aspects must have those aspects
assessed by an NB.
IVD reclassification also impacts quality system
requirements. With the exception of Class A, all products
require, at a minimum, a full quality management
system, audit with an NB, and review of at least one
technical file per generic device group. Class D devices
also require batch verification and reference laboratory
involvement.2
Requirements for Clinical Evidence
While a CE mark under IVDD may have only required
analytical data, the IVDR specifies and defines the
clinical evidence requirements that is proportionate
to the risk class of the device. For products that are
currently on the market, post-marketing surveillance
data can be used to meet the requirements. For new
products, manufacturers may find it useful to use FDA
requirements as a starting point for defining the data
needed to demonstrate sufficient clinical performance
and the design of an appropriate clinical trial.
To comply with IVDR, manufacturers need to
include a clinical evidence report containing scientific
validity, analytical performance, and clinical
performance data in their technical documentation.
This report is meant to be a living document that
is reviewed periodically throughout the product's
lifecycle and updated as appropriate.
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