As a substitute, the European Aviation Safety Agency (Easa) will run its tests on the airplane earlier than approving a return to commercial flights.
The 737 Max has been grounded since March after two deadly crashes.
However, Easa instructed the US Federal Aviation Administration (FAA) there could be “no delegation” on safety approval in a letter sent on 1 April.
Patrick Ky, Easa’s chief executive, revealed a list of four circumstances given to the US authorities in a presentation to the European Parliament’s committee on transport and tourism on Monday.
Europe’s powerful stance is a blow to Boeing’s hopes of a fast return to service for the 737 Max, and can also be a major break with the established worldwide practice of aviation regulators accepting one another’s standards.
The 737 Max airplane has not flown commercially since an Ethiopian Airlines aircraft crashed shortly after take-off on 10 March, killing 157.
It adopted a Lion Air crash on 28 October last year which killed 189.
In each incident, investigators have targeted on the function performed by a software program system known as MCAS (Manoeuvring Traits Augmentation System), which was designed to make the plane simpler to fly.
Probes have shown the software program – and the failure of sensors – contributed to pilots, not with the ability to control the aircraft.
Mr. Ky’s presentation confirmed a refusal to accept delegation was the first of the four circumstances that needed to be met before flights in Europe could resume.
Easa’s work on the 737 Max had entailed “an unprecedented stage of the effort,” with 20 aviation experts and two to three online meetings per week with Boeing engineers.
There have been plans for a full week of trial flights with a modified plane at Boeing’s flight test center in Seattle.
Boeing has been engaged on adjustments to the 737 Max’s flight control methods to keep away from the MCAS drawback. In addition to modifications to the airplane, it has proposed changes to the methods pilots are trained.
Reports within the US have instructed that Boeing had hoped for FAA safety clearance next month, with airways free to fly the plane later within the year.
FAA approval would enable US airways to fly the plane. However, European operators – together with Norwegian Air – would wish Easa clearance earlier than returning it to commercial service.