MDR Article 120, amended by Regulation (EU) 2023/607 published on 20 March 2023, sets out the transitional regime allowing certain devices certified under the old directives to remain on the European market, pending their MDR certification.
The transitional regime does not remove the obligation to comply with the MDR. It postpones the deadline for placing the device on the market. The distinction is not merely semantic: it determines what a manufacturer must do, and when.
Why was the transitional regime extended
The initial timeline aimed for a transition completed by May 2024. The real capacity of the system made it untenable: a limited number of notified bodies designated under the MDR, longer assessment times, a volume of files concentrated in the same windows. By 26 May 2024, around 21,000 certificates issued under the directives were due to expire, against a far lower MDR issuance capacity. Regulation 2023/607 extended the deadlines to avoid supply shortages of essential devices.
The deadlines by class, and the exception most summaries forget
Three dates structure the extended regime.
31 December 2027. Class III devices and Class IIb implantable devices. But an exhaustive list escapes this date: sutures, staples, dental filling materials, crowns, screws, wedges, plates, wires, pins, clips and connectors. These devices, although implantable and Class IIb, move to 31 December 2028. This is the nuance that leads to classifying a device a year too early when the regulation is read diagonally.
31 December 2028. All other Class IIb devices, Class IIa devices, Class I sterile devices, Class I devices with a measuring function, and devices self-certified in Class I under the directive whose MDR conformity assessment now requires the involvement of a notified body.
26 May 2026. Special case of custom-made Class III implantable devices, subject to their own timeline.
These dates are not certification targets. They are the deadlines for placing devices on the market under a directive certificate. Beyond them, without MDR certification, marketing in the Union stops for the class concerned.
The cumulative conditions: five, not three
Article 120 does not extend any certificate automatically. The benefit of the regime requires conditions that must all be verified, together.
The device continues to comply with the applicable requirements of the directive under which it was certified (MDD). No significant change to the design or intended purpose is introduced, within the meaning of the MDCG 2020-3 guidance that sets out the criteria. The device does not present an unacceptable risk to health or safety.
To these are added two operational deadlines, and their dates are the real breaking points. By 26 May 2024, the manufacturer had to have a quality management system compliant with Article 10 of the MDR, and to have filed a formal conformity assessment application with a notified body. By 26 September 2024, a written agreement had to be signed with that body. The absence of an agreement by that date causes the loss of the benefit of the regime. With no catch-up.
What the transitional regime does not cover
The transitional regime covers placing on the market, not the full set of regulatory obligations. A legacy device is subject, as of now, to a growing share of the MDR: post-market surveillance, vigilance, serious incident reporting, market surveillance, registration of economic operators, and UDI and EUDAMED obligations as they become applicable. The manufacturer therefore manages, in parallel, certain requirements of the directives and a growing fraction of the MDR. The transitional regime is not there to defer these obligations.
The end of the “sell-off”
Regulation 2023/607 abolished the “sell-off” mechanism, that is, the cut-off date beyond which a device already placed on the market could no longer be distributed or put into service. A device legally placed on the market during the transitional period may now continue to be made available or used without time limit, subject to its lifetime or expiry date.
The transitional regime rewards commitment, not waiting
Article 120 does not postpone the transition. It grants it to manufacturers who initiated it on time. Verifying that a device still meets the five conditions, for its class and at its date, is a regulatory qualification exercise before being a scheduling exercise. It is also the first point an MDR compliance audit puts back on the table.
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