The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application.
The Parliament has tabled and supported the 4 technical amendments proposed last week by the European Council, without bringing additional changes.
All three EU institutions now support:
- Postponing the MDR Date of Application by one year, plus all other references to this date in the MDR transitional provisions – from 26 May 2020 to 26 May 2021.
- Bringing into immediate application of the possibility for EU-wide derogations as foreseen in MDR Article 59(3).
The MDR amendment is expected to be published in the EU Official Journal by end of April. Many steps must still occur before this change to MDR is official, but the good news is that the process is in place. We will continue providing updates as we receive them.