On May 5th the European Commission published two new medtech regulations, the in vitro diagnostic medical device regulation (IVDR) and the medical device regulation (MDR).
The regulations will come into force on Thursday May 5th 2017. MDR will replace the former regulations 90/385/EEG and 93/42/EEG and IVDR will replace the former regulation 98/79/EG.
Now begins a transition period of three years for medical devices and five years for IVDs, which means that the new rules will fully apply at the end of May 2020 for medical devices and at the end of May 2022 for IVDs.
“The medical technology industry welcomes the fact that the transition and implementation period has finally come,” said Serge Bernasconi, CEO of MedTech Europe in a press release. “Now we open a new chapter – the industry is ready to collaborate with all actors to ensure a timely and smooth transition to the new Regulations.”
For the in vitro diagnostic sector, this new regulation represents a fundamental legislative change with new or major shifts in areas such as the classification system, performance evaluation and clinical evidence, and conformity assessment of IVDs, reports MedTech Europe. For the medical device sector, the new regulation brings more detailed clinical evaluation requirements, a new “scrutiny” process and an increased Commission and Authority control and monitoring of a strengthened notified body system.