Examining Device Packaging and Sterilization Options

Packaging and sterilization are dynamic markets these days in the medical device industry, thanks to the new EU Medical Device Regulation (MDR), the COVID-19 pandemic, wobbly supply chains, tougher regulations, and changing healthcare demands. Although there is still an abundance of change to contend with, medical device manufacturers (MDMs) are settling (cautiously) into a “new normal” for packaging and sterilization. However, “there is still some pressure on supply chains with raw material shortages, especially with recent market tightening for sourcing and lead times,” said Tom Williams, general manager for Millstone Medical Outsourcing, a Fall River, Mass.-based provider of packaging and distribution solutions for the medical device industry.

With the EU MDR newly launched, MDMs that are still behind are hustling to convert from non-sterile to sterile packaging. With MDR’s sharper focus on risk and safety, grandfathered devices with a CE mark will require recertification.