The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA last week got a preview of the comments it can expect in response to its unique device identifier (UDI) draft rule ranging from whether a change in UDI would require a new supplemental PMA or 510(k) to questions about date formatting required by the rule. Dan O’Leary, president of Ombu Enterprises, noted that the rule raises a number of challenges — especially for companies with fewer than 50 employees that may lack the resources to implement it. Devices & Diagnostics Letter