EU MDR Update: What the Latest Extensions Mean for US Companies

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The EU Medical Device Regulation (MDR), Regulation (EU) 2017/745, was adopted in 2017 and has applied since May 26, 2021. Its timetable for devices certified under the earlier directives has moved more than once. The extension that matters most today came from Regulation (EU) 2023/607, which set deadlines of December 31, 2027 and December 31, 2028 for legacy devices that meet its conditions. US medical device companies still face real decisions about their European strategy.

The Current Transition Deadlines

Regulation (EU) 2023/607, adopted on March 15, 2023, extended the period during which devices certified under the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive can continue to be placed on the market. The previous deadline was May 26, 2024. The new deadlines are:

• Class III devices and Class IIb implantable devices (with exceptions such as sutures, staples, screws and plates): December 31, 2027
• Other Class IIb devices, Class IIa devices, and Class I devices that are sterile or have a measuring function: December 31, 2028
• Class III custom-made implantable devices: May 26, 2026, without a notified body certificate

The extensions are conditional. A legacy device qualifies only if it continues to comply with the relevant directive, has no significant changes in design or intended purpose, and does not present an unacceptable risk to health or safety, and only if the manufacturer had an MDR-compliant quality management system in place by May 26, 2024, had lodged a formal application with a notified body by May 26, 2024, and had signed a written agreement with that notified body by September 26, 2024.

What the Extensions Did Not Change

• New devices, and legacy devices that do not meet the conditions, need MDR certification before they can be placed on the market
• A significant change in a legacy device's design or intended purpose ends its eligibility
• The MDR's requirements for post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply to legacy devices

Two later developments are also relevant. Regulation (EU) 2024/1860, adopted on June 13, 2024, allows a gradual roll-out of the EUDAMED database and, from January 10, 2025, requires advance notice of an anticipated interruption or discontinuation of supply of certain devices. And on December 16, 2025, the European Commission proposed a targeted revision of the MDR and the In Vitro Diagnostic Medical Devices Regulation intended to simplify the rules and speed up conformity assessment; it must be adopted by the European Parliament and the Council, likely with changes, before it applies.

Implications for US Companies

Companies with Existing CE Marks

For devices certified under the MDD, the extensions provide time, not an exemption. Questions to check:

• Did the company meet the 2024 conditions (quality management system, notified body application and signed written agreement) for each legacy device it relies on?
• Can its notified body complete MDR certification before the applicable deadline?
• Would planned product changes count as significant changes that end eligibility?
• Is the clinical evidence the MDR requires being built, and are MDR post-market surveillance and vigilance obligations being met?

Companies Planning European Entry

For US companies not yet in Europe, there is no legacy route: a new device needs MDR certification. Planning should account for notified body availability and review timelines, the clinical evidence the MDR expects, and whether the European opportunity justifies the cost of certification.

Strategic Considerations

• Market sizing: is the European market large enough to justify MDR certification?
• Competitive timing: will competitors' MDR status affect who can sell in Europe, and when?
• Clinical data strategy: can European clinical evidence requirements be aligned with the US program?
• Partnership options: would a European partner be more efficient than direct market entry?

The Bottom Line

The 2023 extensions gave legacy devices more time, on conditions that had to be met in 2024. New devices reach the European market only through MDR certification, and the Commission's revision proposal can change parts of that process only once it is adopted. For diligence, the practical questions are which of a company's devices rely on the transition, whether each met the conditions, and what the certification plan is for the 2027 and 2028 deadlines.

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