On 26 May
2025 we are celebrating the 3rd anniversary of the IVDR (Regulation (EU)
2017/746 on in vitro diagnostic medical devices). In addition, there are
three important due dates that IVD manufacturers must consider to continue
marketing their legacy IVDs on the European market:
·
All
IVD manufacturers must now have an IVDR-compliant Quality management system (QMS),
including a system for Post market Surveillance (PMS)
·
Manufacturers
of IVD devices having a CE certificate under the IVDD, must have lodged a
formal application for the IVDR transition with an IVDR Notified Body. The manufacturer
and the Notified Body must agree on the extension of the CE-certificate.
·
Manufacturers
of IVD devices that were self-declared under the IVDD and are classified as
class D under the IVDR, must have lodged a formal application with an IVDR
Notified Body for their devices. The Notified Body shall review the
applications before 26 September 2025.
For IVDR
class C, class B and class A/sterile legacy devices, similar due dates will
apply in 2026 and 2027 as illustrated in the figure below.
Once the
transition deadline has passed, specific IVD class legacy devices that will not
make the transition to the IVDR can only be placed onto the EU market under the
sell-off provision. During the entire transition time, all legacy devices shall
continue to meet the IVDD requirements and must not present an unacceptable
health or safety risk. No significant changes can be made to the device or its
intended purpose.
State of the play – the clock is still ticking …
In May 2022,
we described the transition from the much lighter IVDD (Directive 98/79/EC on in
vitro diagnostic medical devices) as a major cultural shift for the IVD
industry. Three years later, the IVDR cannot be called “new” anymore. But even
with a second amendment to extend the transition times for IVDD legacy devices
and prevent shortages in IVD devices, many manufacturers are still facing
challenges for the timely transition of their product portfolios to the IVDR.
With a
total of 15 Notified Bodies designated for the IVDR and Notified Bodies indicating
that they have capacity for review of Technical Files and for QMS certification
now, manufacturers should plan and prioritize the application for the IVDR
transition already before the transition deadlines.
While the
European Commission is trying to find ways to ease the regulatory
burden for innovative devices with a focus on SMEs, manufacturers still need to
comply and should not expect another extension of the implementation deadlines.
Notified
Bodies currently have availability for review of new applications within a
reasonable time frame but expect a rush of last-minute applications just before
the end of the transition periods for class C (26 May 2026) and class B (26 May
2027). Keep in mind that as part of the formal application process you will be
required to share information on your company, devices and QMS system including
the intended purpose and classification of each device and the Notified Body may
reject incomplete applications.
Don’t
take your foot off the gas !
Best
practices for ensuring a smooth transition
·
If
you have already prepared IVDR compliant technical documentation, don’t hold
back and postpone your application with a Notified Body. Remember that the
Notified Body review and release of certificates may take up to 18-24 months,
including multiple rounds of questions.
·
If
you are still working on your technical file or the generation of (clinical)
performance data, you need to prioritize these activities to ensure that your
application will be well ahead of the timelines stated above. Don’t wait for
guidance documents.
·
You
can save review time and cost for Notified Body reviewer hours by ensuring your
Technical File is complete and complies with IVDR. And during the review, make
sure you give priority to answering Notified Body questions and providing
additional documentation If requested.
·
Make
sure to address all applicable requirements in IVDR Annexes I – III. Use the Best
Practice Guidance published by Team-NB (the Notified Body Association) and
make sure you follow the specific guidance of your Notified Body, including
numbering and structure of the documentation (e.g., BSI’s IVDR DocumentationSubmissions Best Practice Guidelines.
·
If
you haven’t done so yet, update your QMS documentation to ensure you are fully compliant
with the requirements stated in IVDR Article 10 (8) and include IVDR
requirements in your internal audits.
What if you are running out of time?
Qserve can support you to navigate through the IVDR transition.
Understanding the expectations and the “how to” of writing technical files is
key to ensure a smooth Notified Body review process. Our experts can provide training
and mentoring to your staff through technical file creation to gain the benefit
from our experience in working with many different IVD manufacturers.
Our IVDR services include:
·
Support
for selecting a Notified Body and navigating through the application process
·
Notified
Body like review of your Technical Files and advice for gap remediation
·
Notified
Body like QMS audit against ISO13485 and IVDR requirements
·
Review
of clinical data and advice on clinical evidence generation and study design
·
Hands-on
support in writing your regulatory documents /technical documentation
Contact us
to learn more!