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Mar 27

Proposed delay to MDR and IVDR regulation

As a result of the current COVID-19 pandemic, the European Commission has announced its intention to propose a delay to the upcoming deadlines for both the EU Medical Devices Regulation (MDR) and EU In-Vitro Diagnostic Device Regulation (IVDR); essentially extending the transition periods for both by 1 year.

The initial decision to introduce these regulations was finalised in April, 2017 and enforced in May 2017, following the culmination of discrepancies and ever-increasingly diverging interpretations found within existing European regulation; kickstarting a 3- and 5-year transition period – ending in May, 2020 for MDR and May, 2022 for IVDR respectively.

In summary, these regulations are wide ranging and will undoubtedly impact many aspects of the supply and control of medical devices – introducing several new requirements in relation to device vigilance – with the intention to bring widespread improvements to the industry, in addition to a modernisation of current system processes; including, but not limited to:

– Enhanced involvement of EU level experts
– Stricter control over high-risk (more invasive) devices
– Reinforcement of criteria for designation and processes
– Inclusion of certain aesthetic devices (i.e. breast implants)
– A new risk classification system for IVDRs
– Improved transparency via an EU database based on unique device identification
– Introduction of an ‘implant card’ for implanted medical devices
– Reinforcement of the rules regarding clinical evidence across the EU
– Strengthening of post-market surveillance for manufacturers
– Improved coordination between EU nations

Initially, both a rolling plan and MDR/IVDR roadmap were provided by the European Commission, to help aid market authorisation holders (MAH) in the successful, timely implementation of both regulations.

However, with the upcoming, proposed delay resulting from COVID-19, the pressure for national authorities; notified bodies who monitor and inspect the devices; manufacturers and MAHs to meet this deadline will possibly be lifted – potentially allowing for resources to be appropriately allocated to business continuity procedures related to the COVID-19 pandemic during this current, uncertain climate.

PharSafer will continue to monitor the situation for any updates – the proposed introduction for the legislation was supposed to happen on 26th May 2020 and so the clock is ticking!

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