On Wednesday 5 April, the European Parliament celebrated the end of the negotiations on medical devices and in vitro medical devices begun in 2012. After discussing the previous day's debate for more than an hour, MEPs formally approved, in a second reading, the Council position, following the compromise reached in May 2016 on these texts (see EUROPE 11559).
The regulation on medical devices (such as implants or pacemakers) will apply three years after its publication in the Official Journal, whilst the regulation on in vitro diagnostic medical devices (such as HIV tests, which do not come into direct contact with patients but allow them to reach a diagnosis) will apply five years after its publication. These two texts are expected to help prevent scandals such as the ones involving adulterated breast implant products manufactured by the PIP company in 2010 and metal hip prostheses in 2012.
The new rules introduce more monitoring before and after the marketing of these devices. They compel the notified bodies, third-party public bodies or private companies nominated by the member states that authorise the marketing of “EC” labelled devices, to employ qualified staff in the medical field or carry out random inspections at the manufacturers after the devices have been put on the market. It also makes manufacturers liable in cases involving damages, which means that manufacturers will have to provide insurance or be part of a compensation fund. In the follow-up field, they also introduced an identification system in order to determine what device a patient has received. The regulation on in vitro devices also introduces ethical criteria for DNA tests that inform patients about the possible ramifications of such tests.
The European Parliament vote is the final stage of the adoption process. It is now up to the Commission, notifying bodies, manufacturers and appropriate authorities to take action to apply the new regulation in the given timeframe. One source close to the dossier explained, “work has already begun but this is just for implementing everything within the relatively short timeframes”. (Original version in French by Sophie Petitjean)