IVDR White Paper 03.06.2020final
IVDR White Paper 03.06.2020final
The In Vitro Diagnostic Directive (IVDD 98/79/EC) As a result, the In Vitro Diagnostic Regulation
was introduced two decades ago to define the (2017/746) or “IVDR” was developed to employ a
requirements for marketing IVD products in the stricter oversight that will encompass many more
European Union. Under the directive, the majority products. The requirements are now a regulation,
of IVD products were self-certified and not subject rather than a directive, which means that it is legally
to oversight by a Notified Body, and some IVDs binding in EU countries. IVDR is longer and
were not even addressed in this directive. expands the scope of compliance to cover more
Innovation in life-sciences developed rapidly and it products as well as define requirements for Notified
became clear to European regulators that the IVDD Bodies. The IVDR follows a life-cycle approach,
was largely inadequate in the fast-changing world demonstrated by The IVDR is about 4
of medical diagnostics technology. incorporating the times longer than the
IVDD it replaces. It
MEDDEV guidances
Over the years, several flaws in the system of contains 10 chapters
and introduces many that are comprised of
Notified Bodies (NBs) were exposed and it became
new concepts and articles (113 in total)
clear that the system needed an overhaul. In and 15 annexes.
requirements.
addition, the IVDD lacked alignment with
international guidelines regarding IVDs.
The IVDR officially came into force in 25 May 2017 transition period, IVDs may be put on the market
with a five-year transition period to full under the IVDD or the IVDR. By 27 May 2024, all
implementation, meaning that it only fully applies CE certificates under the IVDD will become void, if
from 26 May 2022. The timeline for this transition not before.
is outlined in Article 110 of the IVDR. During the
The IVDR introduces a new classification scheme the highest classification will apply to the device.
for IVDs based on GHTF IVD Classification Class A non-sterile devices will be self-certified by
Guidance that is more resilient to changes in manufacturers, excluding sterile devices. Class B,
technology and medicine. Instead of the IVDD’s list- C and D devices require conformity assessment by
based classification, the IVDR’s rule-based a Notified Body.
classification system divides IVDs into four classes
It is highly likely that even if your product was self-
based on their risk profiles. The device classes certified under the IVDD, it will be up-classified under
the IVDR an require NB involvement.
increase with risk, Class A being the lowest risk and
Class D being the highest risk. Classification is
Manufacturers will need to re-assess their product
determined by the intended purpose and considers
to determine which rules apply and justify the
the risks to both the individual and public health.
classification. The following flow chart illustrates
Article 47 of the IVDR discusses the classification,
the application of the classification rules. For an
and the rules themselves are laid out in Annex VIII.
accurate classification of the IVD, please refer to
All seven rules must be consulted to determine the
the IVDR Annex VIII.
device classification the applicable rule leading to
The IVDR lays out several routes for conformity The manufacturer may have some choice in the
assessment depending on the risk class of the IVD route to conformity assessment. The following
which are descried in Annexes IX, X and XI. The table outlines the available routes depending on the
routes to conformity assessment are based on: device class. (The exact requirements are detailed
in the IVDR):
Quality management system and technical
documentation (Annex IX) NBs performing conformity assessment will
request an EU reference lab to verify the
EU Type-examination (includes technical performance claimed by the manufacturer.
documentation) (Annex X)
Production quality assurance (Annex XI)
Determining the classification of your IVDs and deciding which conformity assessment route to take is a key
factor in compliance with the IVDR. Li-Med can assist in this process to ensure a smooth transition.
Annex II details the technical documentation a The GSPR in Annex I is similar to the Essential
manufacturer will need to prepare for a Class B, C Requirements in the IVDD but includes many more
or D product that will be reviewed by a Notified requirements and greater detail. Among others, the
Body. Even though Class A products will not have GSPR includes requirements for performance
their technical documentation reviewed by a NB characteristics, risk
before they are placed on the market, the management, and The GSPR are a core
component of the IVDR
manufacturer must still compile this information. specific devices such and provide the criteria
for safety and
Technical documentation must include: as electronic
performance applicable
Device specification, including intended programmable to all aspects of IVDs,
throughout their life-
purpose, method of operation, etc. systems, self-testing
cycle.
Labels and instructions for use and near-patient
Design and manufacturing information testing.
General safety and performance requirements
Preparing the technical documentation can place
(GSPR) (Annex I)
demands on manufacturers; Li-Med’s experts can
Benefit-risk analysis and Risk Management
help in easing the burden.
Product verification and validation
Performance Evaluation Report (PER) which
includes clinical evidence
Chapter VI discusses the requirements for clinical The Performance Evaluation must demonstrate
evidence, performance evaluation and the following elements regarding the IVD:
performance studies, the details of which are
Scientific validity
described in Annexes XIII-XIV. The requirement for
Analytical performance
clinical evidence and post-market performance
Clinical performance
follow-up are new for IVDs. As mentioned
previously, a Performance Evaluation Report Much of this information can be obtained from
What are the new requirements for vigilance and Post-Market Surveillance?
The requirements for post-market surveillance, Actions (applies to Class A and B and may be
vigilance and market surveillance are outlined in updated as needed)
Chapter VII. Manufacturers must gather and Periodic Safety Update Report which includes
analyze data about post-market activities as part of the same information as the Post-Market
the life-cycle approach to continuously review the Surveillance Report as well as benefit-risk
benefit-risk analysis of their products. Annex III analysis, sales volumes, user population
describes the technical documentation for Post- characteristics, and use frequency. (Applies to
Market Surveillance required for each product. It Class C and D and must be updated annually)
includes:
Requirements regarding vigilance and incident
Post-Market Surveillance Plan which describes reporting are much stricter in the IVDR than the
the system for gathering, recording and IVDD. The timeframes for reporting serious
analyzing relevant quality, safety and incidents are laid out in Article 82 and there are new
performance data regarding the IVD throughout requirements regarding vigilance reporting if there
its life-time. is a significant increase in frequency or severity of
Post-Market Surveillance Report which incidents. Requirements regarding reporting of and
summarizes the results and conclusions of the Field Safety Corrective Actions (FSCA) as well as
analysis of the Post-Market Surveillance data analysis of vigilance information are described in
and include any Corrective and Preventative detail. There is a new requirement to submit
vigilance reports to the EUDAMED database.
The IVDR was introduced to address the some products, it is not financially beneficial to
shortcomings of the IVDD, which has become make the transition and it is better to scrap them.
increasingly inadequate in world with rapidly
While the task of moving to the IVDR may seem
advancing medical diagnostics technology. It
daunting, it is important to understand the
brings regulations regarding IVDs closer in line with
reasoning behind it. Safety of the individual and the
international regulations, such as the FDA, and
public should always be the number one priority in
guidances. The IVDR is a regulation and therefore
healthcare and medicine. Remember that when
EU member states must apply it in their national
you or a family member receive medical care, you
law.
want it to be at the highest standard. Make sure
IVD manufacturers will have to seriously consider your IVD meets the standards you would expect for
the implications of the IVDR and the new yourself and your loved ones.
obligations placed on them. They may find that for
Li-Med supports medical device and IVD manufacturers overcome regulatory hurdles.