other things, the research, development, testing, clinical trials, manufacture,
storage, recordkeeping, approval, labeling, promotion and commercial sales
and distribution, of many of our products.
European Union Regulations
In the European Union, in vitro diagnostic medical devices (IVDs) had been
regulated under EU-Directive 98/79/EC (IVD Directive) and corresponding
national provisions. The IVD Directive required that medical devices meet the
essential requirements, including those relating to device safety and efficacy,
set out in an annex of the Directive. According to the IVD Directive, EU Member
States have presumed compliance with these essential requirements for devices
that are in conformity with the relevant national standards transposing the
harmonized standards, such as ISO 13485:2016, the quality system standard
for medical device manufacturers.
IVD medical devices, other than devices for performance evaluation, must bear
the CE marking of conformity when they are placed on the European market.
The CE mark is a declaration by the manufacturer that the product meets all the
appropriate provisions of the applicable legislation implementing the relevant
European Directive. As a general rule, the manufacturer must follow the EU
declaration of conformity procedure to obtain or apply a CE mark.
In May 2022, the Directive was replaced by the In Vitro Diagnostic Device
Regulation (IVDR) (EU) 2017/746 that was published in May 2017 and given
a 5-year transition period until its full implementation on May 26, 2022. Unlike
the IVD Directive, the IVDR has binding legal force throughout every Member
State. The major goal of the IVDR was to standardize diagnostic procedures
within the EU, increase reliability of diagnostic analysis and enhance patient
safety. Under the IVDR as enacted by the European Commission (EC), IVDs are
subject to additional legal regulatory requirements. Among other things, the
IVDR introduces a new risk-based classification system and requirements for
conformity assessments. Under the IVDR and subsequent amendments, IVDs
already certified by a Notified Body under the IVD Directive may remain on the
market until May 26, 2025, and IVDs certified without the involvement of a
Notified Body may be placed on, or remain in, the market for up to three years
(until May 26, 2028) depending on the classification of the IVD. More recently
on January 23, 2024 the European Commission has published a legislative
proposal which would extend the time for legacy IVDs to transition to the IVD
regulation. Nonetheless, the manufacturers of such devices must comply with
specific requirements in the IVDR according to the timelines established, but
ultimately, such products, as with all new IVDs, will have to undergo the IVDR’s
conformity assessment procedures. Under the IVD Directive the majority of
QIAGEN products were classified as self-declared, while under the IVDR most
of QIAGEN products will require pre-approval, and those that are in the highest
risk class will have to be tested by a Designated Reference Laboratory. In
addition, the IVDR imposes additional requirements relating to post-market
surveillance and submission of post-market performance follow-up reports.
The EC has designated twelve (12) Notified Bodies to perform conformity
assessments under the IVDR, including QIAGEN’s Notified Bodies, TÜV
Rheinland and BSI. MedTech Europe has issued guidance relating to the IVDR
in several areas, e.g., clinical benefit, technical documentation, state of art,
accessories, and EUDAMED. On December 5, 2023, the European
Commission adopted Implementing Regulation (EU) 2023/2713 designating
five EU Reference Laboratories covering the following types of high risk, class D
IVDs: hepatitis and retroviruses; herpesviruses; bacterial agents; respiratory
viruses that cause life-threatening diseases. The designated EU Reference
Laboratories are responsible for verifying performance of IVDs in accordance
with common specifications, batch testing of class D IVDs, collaborating with
Notified Bodies to develop best practices for IVD conformity assessments, and
providing scientific and technical assistance on the implementation of the IVDR.
The General Data Protection Regulation (GDPR) of the European Union,
imposes restrictions on the transfer, access, use, and disclosure of health and
other personal information. We have implemented the requirements set forth by
the GDPR, which took effect on May 25, 2018. GDPR and other EU data
privacy and security laws impact our business either directly or indirectly. Our
failure to comply with applicable privacy or security laws or significant changes
in these laws could significantly impact our business and future business plans.
For example, we may be subject to regulatory action, fines, or lawsuits in the
event we fail to comply with applicable privacy laws. We may face significant
