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Apr 21

2017/745 Medical Device Regulation postponed by 12-months

In response to the European Commission’s (EC) proposal to delay the (EU) 2017/745 Medical Device Regulation (MDR), the European Parliament (EP) conducted a vote on the 17th April 2020 and, with an overwhelming majority, have since announced their decision to confirm a 12-month postponement, with the new deadline now being confirmed for 26th May 2021.

In line with the reasons put forward by both the EC and the European Medicines Agency (EMA), the EP have communicated that their decision to postpone this regulation was due to the impact and pressure being currently witnessed across various national authorities, as a direct result of the COVID-19 pandemic, with the belief that the manufacturing and supply of essential medical devices would be significantly and detrimentally impacted by a May 2020 deadline.

Consequently, through confirming this decision, there is a belief that industry organisations can now begin to allocate their resources appropriately and effectively, to help towards battling the current pandemic; whilst not having to further burden themselves with preparations towards complying with the upcoming regulation for the immediate future.

Furthermore, the EP has also communicated that current procedures and existing Directives will remain in place – to ensure a fully operational regulatory framework exists throughout the entirety of this delay, with patient safety remaining as the absolute priority throughout the European Market.

However, it remains worth noting that the existing date of application for the Vitro Diagnostic Medical Device Regulation (IVDR) will not be impacted by this 1-year postponement and therefore will continue to become effective from 26th May 2022; in addition to the MDR delay still requiring to be approved by European member states.

As a result, industry organisations have been urged to continue to prepare in accordance with the aforementioned deadlines, outlined above, and await further notification from their appropriate national authorities.

PharSafer will continue to monitor this topic and communicate any updates via our website and LinkedIn page as we receive them.

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