The EU MDR Deadline … Are We Really Ready?

by | Mar 1, 2019 | EU, EU MDR, FDA, Medical Devices, Quality Systems, Regulatory

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.1

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.1 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.1

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.1

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.1 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.1

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.1

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.


1KPMG (2018) The race to EU MDR compliance retrieved 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

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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