LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.
BOSTON – The transition of the European med-tech regulatory system is not going well, but Oliver Bisazza, director of regulations at Medtech Europe, said device makers should nonetheless continue preparing product dossiers for recertification of existing CE marks because "you have to be able to show them you have been making an honest go of it" where re-certification is concerned.
