EU extends medical device rules to Monaco in joint committee decision

The EU-Monaco Joint Committee has adopted Decision No 1/2026, extending to the Principality of Monaco the European Union’s reformed legislation on medical devices and in vitro diagnostic medical devices. The decision, taken on 28 July 2026 and published in the Official Journal of the European Union (L series, 2026/1964) on 4 September 2026, amends the Annex to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality.

The measure updates the framework last revised by Decision No 1/2013, incorporating the Union’s fundamental reform of health-product rules that was designed to establish a robust regulatory framework ensuring a high level of safety and health protection.

What the decision extends to Monaco

The new Annex brings the Principality under the Union’s modern device regime, centred on the two flagship regulations adopted in 2017:

• Regulation (EU) 2017/745 on medical devices, as amended by Regulations (EU) 2024/1860, 2023/607 and 2020/561;
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices, as amended by Regulations (EU) 2024/1860, 2023/607 and 2022/112;
• Regulation (EU) 2024/1689 (the Artificial Intelligence Act), insofar as it applies to devices;
• the Eudamed European database framework, including Commission Decision (EU) 2025/2371 on the functionality of its electronic systems.

The Annex also retains the earlier device directives — 90/385/EEC on active implantable devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostics — together with their implementing acts on reclassification of breast implants and joint replacements, and the European Databank on Medical Devices (Eudamed).

Joint inspections and scope

Beyond the legislative alignment, the decision addresses practical difficulties encountered in the conduct of joint inspections by the Monegasque and French authorities of laboratories and production facilities established in the Principality. The text is explicit that it neither extends the scope of the Agreement nor creates additional rights beyond those already arising under it.

The Annex covers four product areas: medicines, cosmetic products, medical devices and in vitro diagnostic medical devices. Under Article 1(2) of the Agreement, acts of the European Commission adopted in application of the listed acts apply on Monegasque territory without the need for a further Joint Committee decision.

Signatories and entry into force

The decision was signed at Monaco on 28 July 2026 and at Brussels on 4 August 2026, and entered into force on the day of its adoption. It was signed on behalf of the Joint Committee by:

• Christophe Robino, Government Advisor – Minister for Health and Social Affairs and Head of the delegation of the Principality of Monaco, as Chair;
• Louis Curau, Second Secretary, Mission of Monaco to the European Union, as Secretary;
• Uberto Marchesi, Desk Officer for the Principality of Monaco, European Commission, as Secretary.

For patients, manufacturers and health authorities in Monaco, the decision means that medical devices and diagnostic tests placed on the Monegasque market will now be subject to the same stringent safety, traceability and post-market surveillance requirements as those in the European Union, closing a regulatory gap and strengthening cross-border health protection along the French–Monegasque border.

Source: Official Journal of the European Union, L series, 2026/1964, 4.9.2026 (official reference: Decision No 1/2026 of the EU-Monaco Joint Committee, CELEX L_202601964).