On 24 June 2026, the EU-Monaco Joint Committee adopted a decision replacing the entire Annex to the EU-Monaco Agreement, updating the list of EU health-product acts that apply in Monaco. The update incorporates new EU rules on medical devices and in vitro diagnostic medical devices, and addresses difficulties encountered in joint inspections by Monegasque and French authorities of laboratories and production facilities in Monaco.
The Annex was last amended by Decision No 1/2013 of the Joint Committee, adopted on 19 October 2013. The revision follows a major EU reform of health-product legislation, including a fundamental revision of rules on medical devices and in vitro diagnostic medical devices. The decision does not extend the scope of the Agreement or create additional rights beyond those already arising under it. Acts of the European Commission adopted under the listed acts will apply in Monaco without needing a further Joint Committee decision. The decision enters into force on the day of its adoption.
Policy orientations and trade-offs The decision updates the legal framework to align Monaco with the latest EU health-product regulations, ensuring consistent standards for medical devices and in vitro diagnostics. This enhances consumer safety and facilitates market access for manufacturers. However, it imposes new compliance obligations on Monegasque producers and authorities, who must adapt to the updated EU rules. The decision also streamlines joint inspection procedures, reducing administrative burdens for French and Monegasque authorities.
Impact on stakeholders - EU and Monegasque health authorities: Gain a harmonised regulatory framework, simplifying oversight and cooperation. Joint inspections become more efficient, but authorities must update procedures and training. - Medical device manufacturers in Monaco: Must comply with updated EU regulations, potentially increasing costs for recertification and labelling. However, they benefit from continued access to the EU single market without additional barriers. - Consumers in Monaco: Benefit from enhanced safety and quality standards for medical devices and in vitro diagnostics, aligned with EU requirements. - EU producers: Face a level playing field as Monegasque competitors must meet the same standards, reducing competitive disadvantages.
Institutional follow-up The decision is adopted by the Joint Committee and enters into force immediately. No further action by the European Parliament or Council is required. The European Commission will monitor implementation and may propose further updates to the Annex as EU legislation evolves.