New EU Regulation on Medical Devices
The European Commission published the Medical Device Regulation (MDR) 2017/745 on 5 May 2017 in the Official Journal of the European Union (OJEU). The MDR will replace the Active Implantable Medical Devices Directive (90/385/EEC -- AIMD) and the Medical Devices Directive (93/42/EEC -- MDD), and will be fully implemented in May 2020.
What does the new Regulation change? It will require clinical investigations to obtain CE mark (i.e. mark of European conformity) for implantable class III and active class IIb devices delivering or removing drugs. It also contains provisions on coordinated mechanisms at the EU level for the authorisation of clinical trials by competent authorities (not by ethics committees), and for the reporting of adverse events, with a single sponsor in the EU, and a single electronic portal. An EU database (EUDAMED) will also be developed, with a medical device identifier (IUD), and scientific advice will be provided by expert groups.
Postponed Implementation of EU Clinical Trial Regulation
The EU Clinical Trial Regulation implementation was foreseen in October 2018. Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed. The European Medicines Agency (EMA) will provide an update at the next meeting of the Management Board in October 2017. Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled.