The way clinical trials and investigations will be conducted in the European Union (EU) will undergo major changes in 2020.  Both trials with investigational medicinal products as investigations with devices are facing the implementation of new EU regulations.

The Clinical Trial Regulation EU No. 536/2014 entered into force on 16 June 2014;  the timing of its application depends on the development of a fully functional EU clinical trials portal and database. The Regulation becomes applicable six months after the European Commission publishes a notice of this confirmation. The entry into application of the Regulation is currently estimated to occur in 2020.

The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements.

It will also make it easier for pharmaceutical companies to conduct multinational clinical trials, which should increase the number of studies conducted within the EU

On 5 April 2017, the EU Regulation on Medical Devices No. 2017/745 was adopted. This regulation  entered into force on 25 May 2017 and will progressively replace the existing directives. The new regulation will be fully applicable in May 2020 and establishes a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. This in turn will boost confidence in our medical devices industry.

At AML we are ready to embrase the changes and face the challenges these new regulations will bring in our daily work.