The EU MDR Deadline ... Are We Really Ready? discusses a survey of over 200 medical device companies on their preparedness for the upcoming EU MDR deadline. The survey found that 54% do not have a strategy for addressing the new regulations, 41% have not measured their long-term compliance capabilities, and 40% have not identified a Person Responsible for Regulatory Compliance as required. Additionally, over 50% lack a clinical data collection strategy and 18% anticipate over 10% of legacy devices will have to be discontinued due to new requirements. The conclusion is that while underprepared, companies still have a year to improve their arrangements before the deadline.

1. The EU MDR Deadline … Are We Really
Ready?
By: Nikita Angane, MS
With the mounting tensions that the new EU MDR has put on medical device manufacturers, the
ripple effects can be seen in every department at those medical device companies.
By default, the regulatory affairs functions have been the worst hit and are struggling to soar up
from the burden of additional requirements to comply with. They not only have to incorporate
the changes but also must make the C-suite level understand and secure their commitment to
comply with it.i
Our blogs on EU MDR will help you understand specifically what these requirements are and
how you can deal with it:
DO YOU KNOW WHAT YOUR TECH FILE SHOULD INCLUDE?
WHAT THE NEW EU MDR MEANS TO YOUR REVENUE
INTRODUCTION TO CLINICAL EVALUATION REPORTS (CERS)
TRANSITIONING TO THE EU MDR? DO YOU HAVE A PRRC YET?
A survey conducted by RAPS and KPMG brought to light how medical device companies are
dealing with the EU MDR.i The survey was conducted in June 2018 with more than 200
companies participating in the survey and the results clearly indicate that medical device
companies do not have a complete understanding of the MDR and that they are still struggling to
satisfy all of the new requirements.
54% of companies admit that they do not have a concrete strategy in place to address the new
regulations. When asked about if they have made an assessment of changes and will they be able
to remain in compliance with it over time. 41% of the survey participants stated that they have
not measured their capability to maintain their compliance with the EU MDR in the long term.i
40% of the participating companies admitted to not have identified a PRRC (Person responsible
for regulatory compliance) yet as required by the regulations while more than 50% of the
participants admitted to not have established any clinical data collection strategy to fill in the
gaps of increased requirements to produce the clinical data for which proving substantial
equivalence has become even more difficult.i

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Also, 18% of the medical device companies anticipate that greater than 10% of their legacy
devices will have to be discontinued from the market because of the new requirements of the EU
MDR and how it does not allow grandfathering of devices.i This could be a big blow for
companies in terms of revenue especially for the small and medium-sized.
Companies also believe that Quality Assurance and Regulatory Affairs departments will have the
most challenging journey towards transitioning into the new EU MDR and maintaining
compliance in the long term.i
Coupled with the fact that only one notified body has gained its certification to conduct
compliance assessment to the EU MDR, 26% of the companies fear that this could pose as a
barrier for them to meet the deadline.i
In conclusion, the survey did showcase how underprepared companies are to meet the deadline.
But fortunately, we still have a year to go and it's not too late for companies to make their
arrangements.
We here at EMMA International are only a call away if you need any help to support your staff
in this transition journey. Please call us at 248-987-4497 or email us at
info@emmainternational.com.
i KPMG (2018) The raceto EU MDR complianceretrieved on 2/28/2019 from
https://institutes.kpmg.us/content/dam/institutes/en/healthcare-life-sciences/pdfs/2018/the-race-to-eu-mdr-
compliance.pdf