With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the medical device industry. Many industry groups and notified bodies have called upon the Commission to postpone the deadline until the end of the pandemic, citing travel restrictions and critical device shortages as roadblocks to the already challenging transition task...

1. COVID-19 Impact on the EU MDR
By: Madison Wheeler
With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR
deadline still looms over the medical device industry. Many industry groups and notified bodies
have called upon the Commission to postpone the deadline until the end of the pandemic, citing
travel restrictions and critical device shortages as roadblocks to the already challenging
transition task.
Despite the pushback from the industry, the European Commission’s Medical Device
Coordination Group (MDCG) is still recommending marching towards the May 26th deadline.
Last week, the MDCG met virtually to discuss the EU MDR transition and draft an
implementation/preparedness plan for it. Unfortunately,since the meeting was held before
Europe became an epicenter for COVID-19 with Italy and Spain going into complete lockdown,
the document does not reference any concerns regarding the outbreak.1 The document does
touch on the risk of notified bodies lacking the capacity to smoothly transition all certifications,
which could potentially be compounded by the pandemic and add to the already critical shortage
of medical devices needed to combat it globally. The MDCG is counting on the December 2019
change that essentially extended the transition period to May 2024 for Class I devices to
mitigate the risk to notified bodies.
The MDCG was unable to quantify the impact of device shortages and disruptions to the
industry, so the group also drafted a second document last week which was intended to reduce
uncertainty and clarify “significant” device changes under the MDR. The terms of the transition
period prohibit significant device changes without being recertified. The guidance document
includes flow charts and other tools to help manufacturers determine if a change is truly
significant under the eyes of the MDR and therefore if the change is allowed before
recertification.2
With travel restrictions, forced quarantines, and other major upheavals in daily life, the medical
device industry is facing an unprecedented time. With the EU MDR deadline still on track, and
the pandemic putting a strain on medical device supplies, there is much to do in a short period
of time. EMMA International has the expertise and bandwidth to help your team through
whatever roadblocks are still to come in the face of the COVID-19 pandemic and the EU MDR
transition with programs like our Outsourced Quality Assurance (OQA) Program®. Give us a
call at 248-987-4497 or email info@emmainternational.com to see how we canhelp!
1 MDCG 2020 (March 2020) Joint Implementation/preparedness plan on the new Medical Devices Regulation
2017/745 (MDR) retrieved on 3/18/2020 from: https://ec.europa.eu/docsroom/documents/40286
2 MDCG 2020 (March 2020) Guidance on significantchanges regardingthetransitional provision under Article120
of the MDR with regard to devise covered by certificates accordingto MDD or AIMDD retrieved on 03/18/2020
from: https://ec.europa.eu/docsroom/documents/40301?locale=en