The US agency's 22-year-old bedrock rule for making safe and effective medical devices to be sold in the United States will likely be replaced with international quality systems standard ISO 13485, FDA official Sean Boyd said at MedCon 2018. But the author of the Quality System Regulation, Kim Trautman, told Medtech Insight that it would be a thorny, years-long chore for the agency.

There are 300 or so medtech standards currently recognized by the European Commission. Will these standards will soon be out of date, or last much longer than companies expect? Even policymakers in Brussels are perplexed.

Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.