MEDICAL DEVICES
Deferment of MDR adopted by European Parliament / Smooth functioning of EU market is vital during Covid-19 outbreak
With strict sanitary measures in place due to Covid-19, the EU parliament allowed members to participate and vote in the plenary session on 17 April from a distance (Photo: European Parliament/Laurie DIEFFEMBACQ) |
On 17 April, the European Parliament voted to adopt the European Commission’s proposal to postpone application of the medical devices regulation (MDR) by one year to 26 May 2021 (see Plasteurope.com of 06.04.2020) in an overwhelming majority of 693 votes to 1 along with 2 abstentions. The parliament said it supports the postponement of implementing the MDR in order to allow authorities and manufacturers to focus entirely on fighting the coronavirus pandemic
The proposal has to now be approved by the member states and published in the EU’s Official Journal before it will come into effect. This is expected by 26 May 2020.
The proposal has to now be approved by the member states and published in the EU’s Official Journal before it will come into effect. This is expected by 26 May 2020.
What is the MDR?
Two new EU regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) were adopted in 2017 (see Plasteurope.com of 03.05.2017). These are intended to improve patient safety and increase transparency on medical devices and include stricter requirements.
The new MDR applies to all medical device manufacturers in the EU and was to be applied on 26 May 2020. Implementation of the IVDR regulation remains unaffected by the new proposal and becomes applicable on 26 May 2022.
The new MDR applies to all medical device manufacturers in the EU and was to be applied on 26 May 2020. Implementation of the IVDR regulation remains unaffected by the new proposal and becomes applicable on 26 May 2022.
23.04.2020 Plasteurope.com [244974-0]
Published on 23.04.2020