Today EU Parliament voted in favor to amend the MDR Article 120 transition provisions, in its first reading. The text on adoption of the extension is available: HERE
Per the adoption text “The European Parliament ….
- Adopts its position at the first reading hereinafter set out;
- Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amends or intends to substantially amend its proposal;
- Instructs its President to forward its position to the Council, the Commission and the national parliaments.”
Due to the urgency of the situation:
“…this Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union.
For the same reasons, it is also considered to be appropriate to invoke the exception to the eight-week period provided for in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union…”