CE marking and the MDR: checking that a defibrillator is compliant

Regulation (EU) 2017/745 on medical devices, known as the MDR, was published in the Official Journal of the European Union on 5 May 2017 and has applied since 26 May 2021. Its Rule 22, in Annex VIII, explicitly places automated external defibrillators in class III, the highest risk class. That rule covers active therapeutic devices with a diagnostic function that determines patient management, which describes a DAE (AED) precisely: it analyses the heart rhythm, decides whether a shock is warranted, then delivers the energy.

Under the former Directive 93/42/EEC, these same units were class IIb. The change is not cosmetic. It brings a reinforced conformity assessment carried out by a notified body, stricter post-market surveillance and traceability through the unique device identifier, or UDI. For an operator the practical consequence is simple: a DAE sold lawfully in France must be traceable to a certificate that is still valid, and your supplier must be able to show it to you.

A CE marking on its own proves nothing for a DAE. On low-risk products, the manufacturer affixes the symbol under its own responsibility. For a class III device, a notified body must be involved, and that body is identified by a four-digit number placed next to the CE symbol. A defibrillator carrying a bare CE mark, with no number, should raise an immediate red flag.

Turn the unit over or open its instructions for use and look for three items: the CE symbol followed by the four-digit number, the unique device identifier as a barcode or two-dimensional code, and the manufacturer's name with an address in the Union. Photograph that rating plate on delivery. A dated picture is worth more than a verbal assurance on the day an inspection asks where your equipment came from.

Article 14 of the regulation sets out obligations specific to distributors. Before making a device available, the distributor verifies the CE marking and the EU declaration of conformity, checks the labelling and the instructions for use in the required language, complies with the storage and transport conditions set by the manufacturer, and passes complaints and incidents on to the manufacturer. Importers are subject to comparable verifications. In other words, your seller is already required to hold these items: asking to receive them is no favour.

So insist on three documents at quotation stage, not after delivery. The manufacturer's EU declaration of conformity, naming the device and the legislation it complies with. The notified body certificate, with its expiry date and the framework it refers to, MDR or Directive 93/42/EEC. The instructions for use in French, which condition the validity of placing the device on the national market. File these documents alongside the invoice and the maintenance contract: they form the foundation of your records.

Many units still on sale carry a certificate issued under the former directive. Regulation (EU) 2023/607 of 15 March 2023 amended Article 120 of Regulation (EU) 2017/745 to extend the transition period for these legacy devices. Class III devices, including automated external defibrillators certified under Directive 93/42/EEC, may be placed on the market until 31 December 2027, provided that the manufacturer lodged an application for assessment with a notified body before 26 May 2024 and signed a written agreement before 26 September 2024.

That extension remains conditional on continued compliance with the directives, on the absence of any significant change in the design or intended purpose of the device, and on the manufacturer having put a quality management system in place. The same text removes the sell-off deadline: devices lawfully placed on the market before the end of the transition may continue to be made available. In practice, if the unit you are offered still falls under the directive, put a single question to the seller: did the manufacturer start the procedure within the deadlines set by Regulation 2023/607? A written answer is enough.

The 31 December 2027 deadline concerns placing on the market, not use. A defibrillator lawfully purchased and installed on your premises does not become unlawful on 1 January 2028 and does not have to be replaced on that ground alone. It remains usable as long as it is kept in working order in line with the manufacturer's instructions, which your maintenance contract and safety register must be able to demonstrate.

The real risk is logistical. A model that does not make it through the transition eventually drops out of catalogues, and its pads and batteries go with it, since they are specific to each unit. Pads are replaced every 2 to 5 years and batteries every 3 to 5 years, whereas a DAE lasts 8 to 10 years and often longer. If your unit is approaching 8 years of service in 2028, check the stated availability of consumables now. This question plays out differently depending on how the device is held, a subject we cover in our articles on the lifespan of a defibrillator and on choosing between renting and buying: with rental from 50 euros excl. VAT per month including maintenance, renewing the fleet is the provider's responsibility, not yours.

French public-access buildings (ERP) have been progressively equipped since 1 January 2020 for categories 1 to 3, since 2021 for category 4 and since 2022 for certain category 5 premises. An inspection rarely looks at the mere presence of the unit: it checks that the device is identified, maintained and documented. The table below lists the information to consolidate for each unit.

Keep this record up to date after every intervention and every change of consumable. The day a notified body, a manufacturer or an authority issues a field safety notice about a model, the one thing that will save you time is knowing within thirty seconds whether you are affected. It is also what allows your provider to schedule replacements before a failure rather than after one.