We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was hard-hitting while some were received with a warm welcome by industry professionals. It sure is a difficult and confusing time for the medical device industry to adopt these new changes, while still being able to maintain the financial stability to incorporate the new global regulations...

1. Your 2019 Wish List!
By: Nikita Angane, MS
We witnessed several changes in the medical device industry in the year 2018. The
impact of some changes was hard-hitting while some were received with a warm welcome by
industry professionals. It sure is a difficult and confusing time for the medical device industry to
adopt these new changes, while still being able to maintain the financial stability to incorporate
the new global regulations.
We here at EMMA International thought of putting together a quick list to help you plan
your compliance goals for the year 2019. Whatever your needs are, EMMA International has the
expertise to help you all the way.
 Thinking about marketing your device in Canada? You will need your MDSAP certificate
in place first. The transition period for device makers to obtain MDSAP certificates has
officially ended on December 31st, 2018 and on January 1, 2019, Health Canada will
only allow MDSAP certified companies to legally market their devices in Canada.
 The biggest event in 2019 for the medical device industry throughout the world is the
Brexit. Britain is set to exit from the European Union on March 29, 2019. No deal has
been struck between the two parties yet. We mentioned in our blog “A NO-DEAL
BREXIT AND THE IMPACT ON MEDICAL DEVICES” a few weeks ago the
consequences that the medical device industry will have to face in the case of a No-deal
Brexit. A quick recap of some measures that you can take until any decisions are
finalized:
o Appoint an authorized representative (AR) in the EU if your current AR is based
in the UK
o If you currently hold a CE mark from a notified body based in the UK, you might
have to transfer the certificate to an EU-based NB to continue marketing your
device in Europe
 We are currently in the transition period to comply with the EU-MDR, which is set to get
into force in May 2020. So, if you haven’t started transitioning into the new EU-MDR or
are stuck in the process and need help, EMMA International can help you succeed and
obtain your goals and objectives.
 A huge announcement was made by the FDA commissioner, Dr. Gottlieb, to align the
FDA’s QSR [21 CFR Part 820] with ISO 13485:2016 in FDA’s Fall unified agenda. The
impact of which we discussed in our blog “FDA TO ALIGN WITH ISO 13485:2016”. The
decisions are to be finalized in the Spring of 2019. However, to be ahead of the game,
you can start preparing by conducting a gap analysis of your quality system to comply
with ISO 13485:2016 and avoid any last-minute disruptions. Of course, EMMA
International can do this and all the other heavy lifting for you, so you are ready for this
transition with a world class QMS.

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 Planning to file a 510(k) for your new device? A statement released by the FDAi
in
November 2018 states that all the new 510 (k) submissions will now have to prove
substantial equivalence to a device that is not more than 10 years old. Thus, if you have
already decided on a predicate for your new device that is more than 10 years old, you
might have to reconsider it before filing your 510(k).
 The FDA has once again proved that it has taken up a new approach of conducting
more inspections to ensure that companies stay in compliance with the QSR, rather than
undertaking enforcement actions. It is always a good idea to be prepared at all times for
an FDA inspection. Having said that, we can help prepare you and your team with our
pre-audit tool kit and engage in a remediation plan to achieve the desired state of
compliance. If you have received a 483 or a warning letter already, then give us a call
right away and we will advocate for you.
 Whatever your business goals are, be rest assured that all your compliance needs will
be taken care of by EMMA International. Start the new year off right by calling us and
accomplishing all your new year goals. You can reach us at 248-987-4497 or
info@emmainternational.com.
i FDA (November 2018) Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D.,
Director of the Center for Devices and Radiological Health, on transformative new steps to modernize
FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices retrieved
on 01-02-2019 from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm