The European Parliament voted today to postpone implementation of its new Medical Device Regulation (MDR) by one year, giving medtech companies a welcome reprieve from their scramble to comply. EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021, if individual member states approve. Get the full […]
European Parliament
European Parliament tightens medical device regulations
The European Parliament voted today to tighten its regulations on medical devices and diagnostics, enacting stronger post-market surveillance rules and adding a safety check for high-risk devices. The new rules, which also mandate a unique identification system and implant cards for patients, are slated to go into effect 3 years after they’re officially published in […]
EU Parliament: No PMAs here please
The European Parliament today failed to back an EU panel’s recommendation to enact strict requirements for medical device approvals that would have matched those required by the FDA’s pre-market approval program.
The EU body voted instead to strengthen the rules by authorizing unannounced inspections and more stringent monitoring of the "notified bodies" that govern medical device regulation there.
