New European Medical Device and IVD Regulation – Where is it?

The long anticipated wait for agreement and adoption of the new European Medical Device and IVD Regulations will go on a little longer. Current predictions are that the new legislation will be adopted no sooner than Q4 2015, possibly extending in to 2016.

There appears to be broad agreement from industry and regulators that the main aspects of the proposals are positive and will be adopted –  stronger vigilance and post-market surveillance systems, improved notified body oversight, greater emphasis on clinical evidence, a standardised Unique Device Identification system and greater transparency to the general public through use of central registration databases.

Debate continues regarding the proposed pre-market scrutiny procedure for high risk medical devices. Industry groups have generally opposed this proposal, disputing its necessity and arguing that it will stifle innovation, resulting in significantly higher costs and a longer time to market for medical devices which could benefit the public. This item is under review and discussion, with France continuing to support a pre-market scrutiny mechanism whilst many Member States support a ‘scrutiny’ made up of a strengthened notified body, clinical evaluation, market surveillance and vigilance approach instead of the pre-market ‘scrutiny’ procedure proposed by the Commission for high risk devices.

Once the legislation is adopted, a 3 year transition period for the Medical Device Regulation is foreseen. Major changes to the IVD classification system along with new requirements for clinical evaluation of IVDs mean that a 5 year transition period is likely to be agreed upon for the IVD Regulation.

Visit the European Commission website for further details on the proposed regulations http://ec.europa.eu/growth/sectors/medical-devices/documents/revision/index_en.htm

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