The long-awaited Mdcg 2021-25 guidance on legacy medical devices was published in October 2021. These clarify several outstanding questions about which articles of the regulation to apply.
The general rule in Article 5 of the MdR is that as of May 26, 2021, any medical device must be placed on the market only if it complies with the new regulation. Article 120, however, establishes an exception by allowing a good portion of devices (called “legacy” devices) to continue to be placed on the market in accordance with the previous directive. More precisely, these are
– class I devices ex Mdd which, according to the new classification in MDR, will require a certificate from the notified body (Nb) provided that the Declaration of Conformity was issued before 26 May 2021 (see also Mdcg 2020-2 “Class I Transitional provisions under Article 120 (3 and 4) – (Mdr)”;
– Class I “measuring function” or “sterile” devices;
– Class IIa, IIb and III ex-Directive devices with ex-Mdr certificates issued by the Nb before May 26, 2021.
Excluded from this exception – and therefore required to comply with Mdr as of May 26, 2021 – are class I devices that continue to be class I in Mdr and custom-made devices. The deadline of May 26, 2021 – established by article 120 – for the drafting of the Declaration of Conformity must be understood in substantial terms: that is, the manufacturer must have carried out and correctly completed all the conformity assessment procedures envisaged by the Directives by that date. On this point the already mentioned Mcdg 2020-02 states that “On the basis of the Declaration of Conformity and the corresponding technical documentation, the manufacturer should be able to demonstrate that the Declaration of Conformity was lawfully18 issued before 26 May 2020”.
But how long will the manufacturer be able to put legacy products on the market? Those of Class I (which will require the Nb in MDR) can be placed on the market no later than 26 May 2024, while those of Class IIa, IIb and III can use the expiry date of the Declaration of Conformity and, in any case, not go beyond that date. In both cases, however, it is foreseen that the legacies placed on the market under article 120 Mdr cannot be “made available” beyond May 27, 2025. As a result, distributors who typically handle the making available of the manufacturer’s devices will have to resell the legacies they have by that deadline to avoid being left with unsold products in stock.
However, the above rules do not apply to second-hand sales, which may take place even after May 27, 2025: this conclusion was already reached by the Compent Authorities for Medical Devices with the Camd Transition Sub Group called “Faq-Mdr Transitional provisions”. In fact, question 18 excludes the operation of the time limit in case the legacy is received by the final user (ex Hospitals) and then resold by the latter.
Legacies may benefit from an additional marketing period (commonly referred to as the “transitional period”) if the following conditions are met
– dm’s maintain compliance with the directives;
– no “significant changes” are made (see MDC 2020-3 and our follow-up article);
– the MDR discipline regarding post-market surveillance, market surveillance, vigilance, registration of economic operators and devices is respected.
MDCG 2021-25 goes into the specifics of these obligations and of the control to be carried out by the Notified Body (article 120, paragraph 3, last paragraph). More precisely, the provisions of the MDR that the legacy manufacturer must still comply with are as follows:
– establishment and maintenance of a “post-marketing surveillance system” provided for in art. 83 Mdr;
– definition of a “Post-marketing Surveillance Plan” in accordance with article 84;
– drafting of the “Post-marketing Surveillance Report” as per Article 85 Mdr provided for Class I legacies;
– preparation of the “Periodic Safety Update Report” per Article 85 Mdr provided for Class IIa, IIb and III Legacies;
– immediate adoption of “corrective actions” in accordance with Article 10, paragraph 12;
– reporting of “serious incidents” and “trends” as required by Articles 87 and 88, respectively;
– analysis of “serious incidents” and “corrective actions” in accordance with Article 89 Mdr;
– registration of the device and its manufacturer’s position in Eudamed (when it is, of course, fully operational), including the identity of any suppliers of raw materials or other.
In contrast, a number of obligations under the MDR are expressly excluded for legacy. in particular:
– the appointment of the “person responsible for regulation” under Article 15 Mdr;
– the revision of the technical documentation in the light of the new Annexes II and III Mdr (except for what is foreseen in the previous list with regard to the obligation to draw up a post-marketing surveillance plan, the post-marketing surveillance report and the periodical safety update report);
– compliance with the new documentation and information obligations foreseen by art. 18 Mdr in favour of the bearer of an implantable device, subject to compliance with any different national regulations;
– the identification of the supply chain pursuant to art. 25 MoR, except for the obligation to comply with further European and national regulations on the traceability of products (for example Directive 2001/95/EC on general product safety);
– the assignment of a Udi Code under Article 27 MDR (this, however, does not exempt the manufacturer from registering it as provided for in Mdcg 2019-05 when Eudamed is operational).
The exclusion of the appointment of the responsible person raises some concerns, considering that this new figure is an active and substantial part of the new post-market surveillance and vigilance system. This can be deduced from “Recital 24” which states: “It should be ensured that the supervision and control of the manufacture of devices, as well as post-market surveillance and vigilance activities relating thereto, are carried out within the manufacturer’s organization by a person responsible for compliance with the regulations and in possession of minimum qualification requirements”. In addition, Article 1 (paragraph 3(c-d)), in listing the obligations of the “person responsible for regulatory compliance”, gives it the task of verifying the manufacturer’s compliance with post-market surveillance and vigilance obligations.
The MDGC then establish that – despite the fact that it does not contain anything in this regard – article 120 MDR must find unequivocal application in respect of “Systems” and “procedure packs” provided they are composed of legacy devices (“It appears logical to apply the transition period also to systems and procedure packs consisting only of ‘legacy devices’ and for which a declaration has been drawn up in accordance with the MDD prior to 26 May 2021”).
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