MEDICAL DEVICES
EU commission postpones MDR application / Shortages in getting devices certified "not an option right now" with Covid-19
 Covid-19 has created extraordinary circumstances that significantly impact various areas covered by the MDR (Photo: PIE) |
As intended, the European Commission has fulfilled its plans to postpone the medical device regulation (MDR) application date (see Plasteurope.com of 30.03.2020). On 3 April, the commission adopted the proposal for a one-year postponement of application of the MDR until 26 May 2021.
The measure is to aid member states, health institutions and economic operators to prioritise actions that reduce the spread of the coronavirus, taking into account the “unprecedented challenges” of the pandemic and the need to maintain EU-wide availability for essential medical devices. The decision will not affect the application date of the in vitro diagnostics MDR, which is set to become applicable on 26 May 2022.
Commissioner for Health and Food Safety, Stella Kyriakides, said, “Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided. Today’s decision is a necessary measure in these very exceptional times.”
The proposal awaits the required support of the European Parliament and the European Council. Here, an accelerated co-decision procedure is expected.
The measure is to aid member states, health institutions and economic operators to prioritise actions that reduce the spread of the coronavirus, taking into account the “unprecedented challenges” of the pandemic and the need to maintain EU-wide availability for essential medical devices. The decision will not affect the application date of the in vitro diagnostics MDR, which is set to become applicable on 26 May 2022.
Commissioner for Health and Food Safety, Stella Kyriakides, said, “Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided. Today’s decision is a necessary measure in these very exceptional times.”
The proposal awaits the required support of the European Parliament and the European Council. Here, an accelerated co-decision procedure is expected.
06.04.2020 Plasteurope.com [244876-0]
Published on 06.04.2020
German version of this article...