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 email@example.com to see how we can help!
1MDCG 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
2MDCG 2020 (March 2020) Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devise covered by certificates according to MDD or AIMDD retrieved on 03/18/2020 from: https://ec.europa.eu/docsroom/documents/40301?locale=en