NEWS
Medical Devices Regulation postponed in Europe
The European Commission has adopted a proposal to postpone the date of application of the Medical Devices Regulation by one year to 26 May 2021, subject to confirmation by the European Parliament and Council. The delay was adopted to allow member states, health institutions and companies to prioritise the fight against the Covid-19 pandemic. The Commission said its decision “takes into account the unprecedented chal- lenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU”. Immediate implementation
Swedish moulder
purchase KB Components has acquired its Swedish compatriot Placell from investment company Captea Markets. Based at Gislaved, Placell turns over about €12m per year through highly automated production of plastic components with gross weights of up to 2.5 kg. KB, whose own
turnover will rise to about €120m per year as a result, said that this will strengthen its position in the Nordic region. �
www.kbcomponents.com
8
Above: The European Commission has delayed application of the regulation until May 2021
might have led to shortages or delays in getting key medical devices certified and on the market, not least due to capacity limitations among authorities and assessors. This decision will not
affect the date of application
of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022. Stella Kyriakides, Commis- sioner for Health and Food Safety, said: “Our priority is to support Member States to
address the coronavirus crisis and protect public health as powerfully as possi- ble – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided. Today’s decision is a neces- sary measure in these very exceptional times.” The new Medical Devices
Regulation is designed to ensure patient safety and increase transparency on medical devices across the EU, said the Commission, but added that the currently applicable rules will continue to guarantee the protection of public health. �
https://ec.europa.eu
Wittmann expands in Hungary
Wittmann Robottechnikai, the Wittmann Group’s production plant in Moson- magyaróvár, Hungary, has taken over a building from neighbouring company Lematex as of 1 April. This will expand the site’s production area by 25% to 15,000 m2
. The Hungarian facility is
responsible for the series production of smaller robot models in the load-bearing capacity range up to 12 kg, plus the basic C90 and C140 temperature controller series. It also supports the Wittmann Battenfeld site in Austria in making SmartPow- er and EcoPower series injec- tion moulding machines up
INJECTION WORLD | April 2020
to clamping forces of 1,800 kN, and sheet metal process- ing machinery. The company said that the Hungarian plant has been “working almost continuously at its capacity
limit and had also reached its limit in terms of existing space”. An expansion is planned in 2021 following the addition of the new property. �
www.wittmann-group.com
Above: Wittmann’s plant in Mosonmagyaróvár, Hungary
www.injectionworld.com
IMAGE: SHUTTERSTOCK
IMAGE: WITTMANN
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