The European Parliament has adopted the Medical Device Regulation (‘MDR’) during its second reading on April 5th, 2017 (see press release attached). The Parliament’s vote constitutes the final step in the legislative process for the adoption of the MDR and confirms the informal political agreement that was reached with the Council and the Commission in May 2016.
The MDR will enter into force on the twentieth day after its publication in the Official Journal of the European Union, and shall, apart from few exceptions, apply from three years after its entry into force. As the publication of the MDR is anticipated in the near future, the MDR is expected to fully apply from mid-2020.
Attached you can also find the recommendation for second reading of the European Parliament’s ENVI Committee. It contains a short justification on the basis of which the ENVI Committee recommends to endorse the MDR without further amendments.
We will keep you informed of any future developments and will provide you with the relevant documents as soon as they become available.
The FEPPD Flash has been prepared for information purposes only and is not intended as legal advice.