by dr. Sunni Patel, medeuronet clinical scientist

Following news that a change to the medical device directive was needed, many are wondering if it will safeguard clinical standards and patient safety.

With the initial proposal released in June of this year, we continue to anticipate further news as the legislation review approaches its final stages; the detailed discussion within the Trilogue.

This process will involve active discussions (and negotiations) between representatives of the Member States, the EU Commission and European Parliament in order to harmonise what could be a game-changing directive.

Meetings are expected to take place from next week and then into November and December in the hopes that the legislation can be finalised for the New Year, and roll-out of adoption across the EU Member States can be met by 2019.

The EU Council finalized its position on the regulation in September, allowing the Luxembourg Presidency to begin its talks with Parliament in order to reach an agreement through the Trilogue as soon as possible.

The key objective of the MDD overhaul is to ensure that medical devices are safe and of high quality, while creating an innovative and competitive EU market . The New Year should bring in new beginnings and tides of whether the Trilogue and final stages of the legislation do indeed allow this to fully materialise.