The European Union’s new Medical Device Regulation (MDR) will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures.
ISO 13485 and every other harmonized standard will need to be revised to conform to the MDR, Dan O’Leary, president of Ombu Enterprises, told attendees at the Medical Device Quality Congress, sponsored by FDAnews.
Ensuring that devices adhere to the new standards will be time-consuming and expensive in many cases, O’Leary said.
Some devices will have to be reclassified under the MDR’s new classification rules. There are four device classifications (I, IIa, IIb, and III) and four groups of classification rules encompassing non-invasive devices, invasive devices, active devices, and a catch-all category of special rules.