In our most recent Qserve Talks podcast, where we talked about several legal issues that are surfacing in many discussions on the details of the new EU MDR, we suggested to write the clarifying blog that is now in front of you. And where in many cases regulatory science is to some extent a science, in this matter it looks more like a believe system, or an art. Either way, in the absence of clear guidance on this matter, choices have to be made, and fast!
The issue is clear. Article 120.3 writes down which elements of the MDR from the Date of Application (currently 26 May 2021) would have to be applied also to legacy products that are already on the market under a CE certificate per the MDD or AIMD. Last revision of the MDR included also those class I products already on the market with a Declaration of Conformity that will have a higher classification, or higher sub-classification, under MDR, i.e. where under MDR a CE certificate from a Notified Body is required. Article 123 on the other hand explains which parts of the MDR under certain conditions are not yet applicable from the Date of Application onwards. The debate starts on the realization that these two concepts of the ‘what to do’ with legacy devices and the ‘what not yet to do’ with MDR devices are not fully overlapping, for example in the field of generating and providing an implant card for legacy devices that under MDR would need an implant card and economic operator obligations for importers and distributors.
Article 120.3, as the heading of article 120 suggest, provides for transitional provisions. These concern devices that have a CE certificate under the AIMDD and the MDD with a validity beyond the date of application of the MDR or a declaration of conformity for a device that would need a notified body assessment under the MDR. Article 120.3 provides that these devices may ride out the CE certificate or declaration of conformity, provided that the manufacturer already implements certain elements of the MDR: post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices in place of the corresponding requirements of the Directives. Article 120.3 is silent on what the manufacturer needs to do with the additional elements of the MDR, such as importer and distributor requirements and the implant card, as referred to above. It could be argued that article 120.3 intends to create a self-contained exemption regime for legacy devices between the date of application and 26 May 2024, but this is not unambiguously stated in the text of the MDR.
Article 123 MDR governs the entry into force and date of application of (parts) of the MDR. Notably, 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 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 assume that everything not delayed under article 123.3 is not delayed. The provisions not delayed include articles 11 – 18 MDR, as these are not mentioned in article 123.3. This is also the position adopted by several competent authorities and is supported by recital 98 of the MDR. Recital 98 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.
Given these two seemingly conflicting regimes, how can a manufacturer reconcile his obligations for legacy device? There are two options. The first option is to treat article 120.3 as a self-contained regime within the MDR, in which the old provisions of the Directives continue to apply, plus only the MDR elements explicitly mentioned in article 120.3. This option requires that the manufacturer is able to run parallel QMS for legacy and MDR products for the duration that he still places legacy devices on the Union market. The second option is to adopt the article 11-18 MDR obligations ‘early’ and also adopt the MDR elements that are not explicitly mentioned in article 120.3 but which are also not delayed under article 123.3. This allows the manufacturer to transition to a single QMS for all devices, which will not only be practical internally but also for the supply chain. Legacy devices and MDR devices are subject to different obligations in the supply chain, or not – depending on whether the manufacturer opts for option 1 or option 2.
From a regulatory perspective, taking in the legal uncertainty as sketched above, one still needs to come to a decision of what to do. Follow the first group of companies that have given in, and to reduce risks of having to accept deficiencies from their notified body, or questions from authorities during their market surveillance activities. Or continue the current path of believing the intention of article 120.3, and the simple fact that 120 precedes 123 and is therefore more powerful. The choice is yours, but a decision on the path to follow should be imminent!
Erik Vollebregt and Gert Bos
Axon Lawyers is a widely respected life sciences boutique law firm with a focus on medical technology, medicines and food. For more information about Axon Lawyers, please visit their website.
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