Navigating the QMSR
What Medical Device Manufacturers Need to Know
What is the QMSR? QMSR vs ISO:13485
The new QMSR (Quality Management Although ISO 13485 and the current Part
system regulation) is the result of aligning 820 are substantially similar, the QMSR
the current good manufacturing practice includes necessary modifications to
(cGMP) requirements of the FDA’s Quality ensure full compliance with all regulatory
System Regulation (QSR) with the requirements. Those already aligned with
international consensus standard for ISO 13485:2016 will face minimal impact,
medical device quality management whereas manufacturers solely focused on
systems, ISO 13485:2016, signifying a huge the U.S. market and currently complying
step towards harmonisation. On February only with 21 CFR Part 820 will experience
2nd 2024, the FDA published the updated significant changes.
21 CFR Part 820 with the publication of the
QMSR. However, the QMSR is expected to
come into enforcement on February 2nd Do we need ISO Certification to comply with
2026, giving manufacturers some time to QMSR?
comply with the new regulation and, for No! You will still need to modify your QMS to
now, continue to comply with the QSR. This meet ISO 13485:2016 but you are not required
final rule is the latest action taken by the to seek certification if you only sell in the US
FDA to promote consistency in the market. However, if you plan to also sell in
regulation of devices. This action will Canada, Europe or Australia, in most cases you
harmonize the FDA’s CGMP regulatory will need to seek ISO 13485 certification.
framework with that used by other
regulatory authorities. Device
manufacturers may need to update So, despite the QMSR and ISO 13485 being
documents and align with the QMSR's relatively similar, there are some
specific requirements, especially regarding significant changes that manufacturers
should be aware of:
risk management and electronic records
and signatures compliance. The QMSR is 1. Terminology (QMSR 820.3) FDA adopts
the ISO terms, replacing DMR, DHR,
concise, indicating the FDA's effort to and DHF.
simplify and make regulations more 2. Records Control (QMSR 820.35 - NEW!)
efficient, focusing on safe and effective QMSR follows the ISO records control,
product manufacturing. Most of the existing including UDI requirements and
confidentiality marking under FOIA.
QSR has been replaced with entirely new 3. Labelling and Packaging (QMSR
sections under the new QMSR. 820.45) FDA retains its labelling
inspection rules, requiring compliance
with both the ISO clause 7.5.1 and
But what if I am not familiar with the ISO? QMSR 820.45.
Well a first good step is to purchase a copy of 4. Risk Management Enhanced focus on
risk management throughout the
the standard and to read it through device lifecycle as per the ISO,
thoroughly. You can find the standard at suggesting possible need for external
https://www.iso.org/standard/59752.html consulting.
What does this mean and what are the implications for manufacturers?
While the new QMSR introduces changes, it closely aligns with ISO 13485:2016, so a
complete overhaul of your QMS isn't necessary. The transition aims to simplify processes
for manufacturers, making compliance more straightforward. It is important to note that
holding ISO 13485:2016 certification does not automatically ensure compliance with the
new QMSR. ISO 13485-certified companies will still be subject to FDA inspections and will
not receive ISO 13485 certification from FDA inspections.
Next Steps for the 2. We have ISO 13485 but not QSR/QMSR
QMSR Transition If you do not intend to sell in the USA, you
should continue to focus on adhering to the
We strongly suggest not waiting to begin
ISO and do not need to make any changes to
your transition to QMSR. Wherever you are
your QMS at this time. If you plan to sell in
in your QMS journey, we can guide you to
the USA in the future, you will need to
start taking the necessary steps to get
prepare for compliance with the FDA’s
ready for QMSR!
QMSR, which aligns with ISO 13485 but has
1. We have QSR but not ISO 13485 some additional requirements. Again, we
recommend that you conduct a thorough
Step one is to familiarise yourself and your
gap analysis to identify differences between
team with ISO 13485. Now is the ideal time
your existing QMS and the QMSR, paying
to increase your understanding of the
particular attention to additional FDA
standard in preparation for the future
requirements that may not be covered by
QMSR. We recommend you follow this by
ISO 13485. Similar to previously, we
conducting a comprehensive gap analysis.
recommend you then create a transition
Identify any gaps between your current QSR
plan to optimise internal processes to align
practices and ISO 13485:2016
with QMSR requirements, before reviewing
requirements. This gap analysis will serve as
and updating documentation to align with
the foundation for your transition plan. This
QMSR standards. Don’t forget to train your
plan should detail actionable steps,
team on all the changes to your QMS!
assigned responsibilities, deadlines, and
metrics for tracking progress. Next,
3. We don’t have anything!
implement the necessary changes to your
quality management system based on the If you have neither QSR nor ISO 13485,
we strongly suggest that you begin by
gap analysis. This may involve updating or
reading the ISO before performing a gap
creating new procedures, documentation, analysis to assess your current
quality policies, and practices to align with processes and identify areas that need
QMSR and ISO 13485:2016 requirements. improvement before developing and
implementing your QMS. Following this,
you can then follow the steps in
Don’t forget undertake a paragraph 1 to incorporate the
comprehensive training program for additional requirements set out in the
QMSR, and become compliant in both
your team on all the changes made!
the EU and USA.
Apotech can support you during your QMSR
transition by providing expert guidance and
To ensure that changes to your QMS are effective,
hands-on assistance.
read the FDA QSIT and conduct internal audits and
use findings to make amendments in preparation for Please don’t hesitate to reach out to use at
your FDA audit!! contact@apotechconsulting.com
(+44) 020 453 254 56
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