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Productwise Bitesize: In Vitro Diagnostic Medical Devices Regulation – Life Sciences, Biotechnology & Nanotechnology

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Productwise Bitesize brings you a short introduction to the In
Vitro Diagnostic Medical Devices Regulation. Since 26 May 2022,
this regulation has been applicable to IVDs, and their
manufacturers, importers, distributors and online sales at a
distance.

What is it called?

The In Vitro Diagnostic Medical Devices Regulation
(IVDR Regulation (EU) 2017/746) governs the making available on the
market in the European Economic Area (EEA) and putting into service
of in vitro diagnostic medical devices (IVDs) and
accessories for such devices. It also governs performance studies
taking place in the EEA. The Regulation has been applicable to
IVDs, and their manufacturers, importers, distributors and online
sales at a distance since 26 May 2022.

Read more

What is it about?

The IVDR is primarily designed to ensure that IVDs made
available on the EEA market fulfil applicable safety, quality and
performance requirements and that IVDs are traceable throughout
their supply chain.

Prior to entry into application of the IVDR, IVDs were governed
by Directive 98/79/EEC on In Vitro Diagnostic Medical
Devices (IVDD). The IVDR introduces a new classification system for
IVDs. This system determines the applicable conformity assessment
pathway, requirements regarding performance studies and the
Technical Documentation that must be prepared for individual IVDs.
The IVDR also imposes stricter requirements on performance
evaluation and post-market surveillance. Furthermore, the IVDR
requires implementation of improved traceability of devices through
the supply chain as compared to the related obligations imposed by
the IVDD.

The IVDR defines the roles of various economic operators, such
as importers and distributors. The Regulation also provides for
specific obligations that individual economic operators must
fulfill. While the obligations that economic operators must fulfil
were previously set down in guidance documents, such as the
MEDDEVs, these obligations are now enshrined in the IVDR. Unlike
its predecessor, the IVDR, as a Regulation, does not require
individual EEA countries to adopt national implementing
legislation. The IVDR will, therefore, lead to a more harmonized
approach to regulation and marketing of IVDs in the EEA. However,
there may still be national requirements introduced in individual
EEA countries such as the language to be used on packaging and
labels of IVDs marketed in their territory, advertising and
promotion, as well as regarding conduct of performance studies.

Who and what does it apply to?

The IVDR is applicable to manufacturers, importers, distributors
and online sellers that supply IVDs for the EEA. The scope of
application of the IVDR has also been specified to explicitly
include companion diagnostics. Moreover, only limited and
restrictive exemptions are provided for IVDs manufactured and used
within health institutions based in the EEA.

The IVDR includes transitional provisions for those IVDs that
have been available on the EEA market prior to the date of
application of the Regulation. The possibility to rely on the
transitional provisions is, however, subject to strict requirements
and conditions. These provisions are not automatically applicable
to all IVDs previously marketed in the EEA. An overview of the
transitional provisions of the IVDR is available here.

Why does it matter?

Given the extensive and stringent requirements that govern the
development, manufacture and marketing of IVDs on the EEA market,
it is essential to ensure that an IVD is classified correctly, that
all related obligations imposed by the IVDR are fulfilled and
documented, and that all economic operators responsible for
manufacturing, importing and distributing IVDs in the EEA fulfil
their obligations appropriately. Non-compliant devices and economic
operators who make these non-compliant IVDs available on the EEA
market may face regulatory enforcement actions by the competent
authorities of EEA countries.

Under the IVDD, only a small number of IVDs were subject to
Notified Body control. As a result of the new classification system
and related conformity assessment pathways introduced by the IVDR,
approximately 80% of IVDs intended to be made available on the EEA
market will now be subject to Notified Body control. For many IVD
manufacturers, the involvement of a Notified Body in the conformity
assessment of their IVDs will, therefore, be a first
experience.

Performance studies may be time consuming and expensive. To save
time and costs it is essential to develop a regulatory strategy
regarding performance studies that will appropriately generate
necessary clinical evidence required to comply with the related
requirements imposed by the IVDR. Sponsors of non-compliant
performance studies may have their applications for related
conformity assessment delayed or rejected.

Furthermore, engaging with economic operators without having a
strategy and compliance framework in place may cause delays and
confusion both in relation to such interactions and to marketing of
IVDs in the EEA. Economic operators marketing IVDs that are not
compliant with the requirements of the IVDR may face enforcement
actions by the competent authorities of the EEA countries.

Where can I find it?

The IVDR is available here.

Is there any guidance?

The Medical Devices Coordination Group (MDCG) of the European
Commission has published a number of related helpful guidance
documents available here. These guidance documents are the
successors to the MEDDEV guidance, published by the European
Commission for the IVDD. The Competent Authorities for Medical
Devices (CAMD) has also published helpful guidance, in particular
on transitional provisions regarding medical devices that were
already placed on the market prior to 26 may 2022. This guidance is
available here.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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