New European Union Medical Devices Regulation Postponed for 1 Year
The new European Union (EU) Medical Devices Regulation (MDR), which was supposed to become fully active on May 26th, 2020, has been postponed for 1 year, in light of the COVID-19 crisis.
The MDR, which replaces the existing Directive 93/42/EEC(MDD), will introduce important modifications affecting all aspects of the supply chain and life cycle for medical devices, aiming to increase harmonization across the region, addressing weaknesses in the current regimes, and increasing protection for consumers.
While this additional year gives the medical device industry some time to prioritize their response to COVID-19-related challenges, they should also diligently continue their effort to prepare the implementation of rules in accordance with general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures, and clinical investigations in order to respond to the obligations set forth in the MDR.
This coming year will obviously be very busy and the medical device manufacturers will likely face the same challenges in 2021 as they do today in terms of clinical data collection as part of their Post-Market Surveillance (PMS), only in an even more difficult regulatory environment.
This delay is an opportunity for medical device manufacturers to rethink their MDR strategy and ensure that they are “MDR ready” in spite of the COVID-19 pandemic.
Med Communications is ready to assist your company in understanding the regulation and aligning your business to be in compliance with the expected changes. Contact Stacy Witham to set up a call with members of our Pharmacovigilance team.
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