Medical device makers based in Ireland are ramping up their recruitment measures to meet stringent new EU regulations that are just months away.
Read moreMedical device makers are on a recruitment drive as strict new EU rules edge closer
Ellina Goncharova
Raw materials: Commission launches new online portal to support responsible sourcing in businesses
Today, the European Commission is launching ‘due diligence ready!’, an online portal that provides businesses with guidance on how to check the sources of the metals and minerals entering their supply chains – the so-called ‘due diligence’ process. It will help them ensure that their use of raw materials respects human rights while improving transparency and accountability across their value chains.
Plastic spoons and spatulas could be poisoning you
Everyday plastic kitchen items like spoons, spatulas and whisks might be damaging your liver or thyroid, scientists have said. They say the plastic utensils produce harmful toxic byproducts that can get into food when they are used at high temperatures and may be poisonous. The toxic byproducts, known as oligomers, are formed unintentionally during plastic production and because they are so small, humans may be ingesting them without knowing. Scientists from the German Federal Institute for Risk Assessment (BfR) are warning people to keep contact with food as brief as possible when using plastic utensils in cooking – especially at temperatures above 70°C.
Another Class I Recall of Ethicon Surgical Staplers, FDA Says
Following seven serious injuries and one reported death, the US Food and Drug Administration (FDA) announced a Class I recall, the most serious type of recall, of some of Ethicon’s Flex Endopath surgical staplers because they may contain an out of specification component within the jaw of the device that could lead to malformed staples.
The Impact of Brexit on Medical Devices Regulation in the United Kingdom
Please find below an interesting article by Morgan Lewis on the impact of Brexit on medical device regulation in the United Kingdom in JD Supra.
U.S. EPA Publishes Updated ENERGY STAR® Requirements for Luminaires
The U.S. Environmental Protection Agency (EPA) has issued an updated version of its energy efficiency requirements for luminaires under the Agency’s ENERGY STAR® program.
Eudamed to Launch in 2022 for Both Devices and IVDs
The European Commission has delayed the introduction of the medical device and in vitro diagnostics registration database until May 2022.
Mazda 3, 6, CX-5 recalled
Mazda Australia has issued a recall for 35,476 diesel versions of its Mazda 3, Mazda 6 and CX-5 model lines over concerns build-up of carbon deposits could cause premature wear of certain engine components.