Be aware that two new EU Regulations entered into force on 25 May 2017, namely:
- Regulation 2017/745 on medical devices (EU MDR)
- Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)
The EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 2022 respectively, but devices can already be placed on the market under these new regulations (if they fully comply with the new regulations).
The new regulations strengthen the vigilance and post-market surveillance requirements for manufacturers.
Changes affecting what needs to be reported to MHRA and when to do it include tighter timescales for manufacturers to report adverse events, the introduction of periodic summary update reports (PSUR) and widening the definition of a medical device to bring more products under scrutiny…