Once the new EU Medical Device Regulation (MDR) came into full force in May 2021, thousands of medical device manufacturers entered the twilight zone – a grace period during which existing CE Marking certificates are still valid under the Medical Devices Directive (MDD) and devices may be distributed in the European Union. Things are not always clear in the twilight zone (which lasts until May 2024) but what IS clear is that Article 120(3) of the EU MDR requires all manufacturers – regardless of whether they only market a device holding a valid MDD certificate or a Declaration of Conformity – to comply with certain aspects of the MDR.
Why MDD Devices Require an Importer When Exported to Europe
Because MedEnvoy is an official medical device importer registered in EUDAMED, we recognize that we don’t exactly offer an unbiased opinion about the need for you to appoint an importer. The MDR is not very about this issue when it comes to MDD products placed on the EU market during the grace period but the downsides of not appointing an MDR importer are not pretty. To get an unbiased expert opinion we asked Erik Vollebregt, an attorney with Axon Lawyers, and considered a leading expert on EU medical device regulations.
Why is there confusion about MDD devices in Article 120(3) of the MDR?
It may be tempting to read Article 120(3) MDR as that it intends to create a self-contained bubble of an exemption regime for legacy devices within the universe of the MDR, valid between the date of application and 26 May 2024, in which only the MDD and the MDR provisions explicitly called out in Article 120(3) apply. This is however not unambiguously supported in the text of the MDR, and the MDR obligations that manufacturers would need to meet are not described very precisely in Article 120(3) MDR. The intention behind Article 120 (3) MDR was to manage the potential bottleneck transitioning capacity from (AI)MDD to MDR certificates in view of the re-notification of notified bodies for the MDR and the work that manufactures needed to do. The intention of Article 120 (3) MDR is, in my view, however not to delay all economic operator provisions in Chapter II of the MDR for legacy devices. This would lead to the chaotic situation that during the grace period (26 May 2021 to 26 May 2024) the Union market would see two different supply chains of medical devices that cannot be distinguished by their label: those subject to importer and distributor verification and other obligations under Articles 13 and 14 and those not subject to those obligations (the legacy devices).
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Beyond Articles 13 and 120(3) is there any additional evidence supporting the need for an importer when it comes to MDD certified devices?
Article 123(3) contains a list of derogations from the principle that everything in the MDR is applicable as of 26 May 2021. Some articles referred to in Article 123 (3) MDR apply before that date (e.g. the articles on national authorities for the MDR and the formation of the MDCG) while others are deferred to later dates, notably Article 123 (3) (d) that delays application of everything to do with EUDAMED until a later date now that EUDAMED is not fully functional before 26 May 2021. Since Article 123 (3) is the exemption to everything applying as of 26 May 2021, one must logically assume that everything not delayed under Article 123 (3) MDR is not delayed. The provisions not delayed include articles 13 – 14 MDR, as these are not mentioned in Article 123 (3) MDR. This interpretation is supported by recital 98 of the MDR, which states that the Directives should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation. This is also the position adopted by several competent authorities as far as I know.
If a company were to have an importer for their MDR certified devices, but no importer for their legacy MDD devices, what additional impact might this have on medical device manufacturers?
This option would require a manufacturer to run parallel quality systems for legacy and MDR products for the duration that he still places legacy devices on the Union market. Furthermore, it requires that his supply chain can tell legacy devices and MDR devices apart and treats them differently, because Articles 13 (importers) and 14 (distributors) and 25 (traceability of devices) do not apply to legacy devices in this interpretation, but they do to MDR CE marked devices.