Proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746

The European Commission has adopted a proposal for a regulation amending the transitional provisions of Regulations (EU) 2017/745 and (EU) 2017/746 for certain medical devices (MD) and in vitro diagnostic medical devices (IVD).

For MD, this text provides an extension of the period until which legacy devices can be placed on the market. It is important to note that these provisions will only apply to manufacturers of devices that meet the conditions listed in this proposal.

The amendment also envisages the removal of the date after which the legacy devices (MD and IVD) can continue to be made available on the market.

The proposal will now be put to a vote in the European Parliament and will enter into force on the day of its publication in the Official Journal of the European Union.

TO DOWNLOAD THE PROPOSAL