In May, the European Union’s sweeping new Medical Device Regulation (MDR) will take effect. (The law had been scheduled to go into effect last May, but was postponed due to the COVID-19 pandemic.)
Recently, a large medical device OEM contracted with NuTec Tooling Systems, a machine builder in Meadville, PA, to design and build a system to automate the process of coating plastic syringes for medical diagnostics, including a COVID-19 application.
FRANKLIN LAKES, NJ—Becton, Dickinson and Co. plans to invest approximately $1.2 billion over a four-year period to expand and upgrade manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems across its six global manufacturing locations and add a new manufacturing facility in Europe.
BOXBOROUGH, MA—German contract manufacturer Vibalogics GmbH is investing $150 million and hiring 100 people for a facility here to help Big Pharma develop a COVID-19 vaccine. The company plans to open the site by the second half of 2021.
LONDON–On January 1, 2021, new regulations by the Medicines and Healthcare Products Regulatory Agency in the UK will require medical devices of all classes to be registered with the agency. These regulations may impact the number of approved medical devices in the future.
BEVERLY, MA–Freudenberg Medical has completed construction of a new medical manufacturing facility here that will produce devices and components in medical- and implant-grade silicones, and high-performance plastics.
ROCK HILL, SC–The FDA has provided 510(k) clearance for a patient-specific, 3D-printed instrument set used during ankle replacement surgery with Exactech’s Vantage Total Ankle System.
RSS
