On 28 September 2022, Legislative Decrees no. 137/2022 and 138/2022 (“Decrees”) entered into force. The Decrees aim to adjust the Italian legal framework to Regulations (EU) 2017/745 (“MDR”) and (EU) 2017/746 (“IVDR”) (jointly, the “Regulations”), replacing a large part of previous national legislation, which was based on the Medical Device Directive (Directive 93/42/EEC of 14 June 1993 concerning medical devices), the Active Implantable Medical Device Directive (Directive 90/385/EEC of 20 June 1990 on active implantable medical devices) and the In Vitro Diagnostic Medical Devices Directive (Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices) (together, the “Directives”).
This article points out some pivotal elements addressed in the two Decrees. The latter have substantially the same content, considering both immediately applicable provisions, and provisions that, to be fully applicable, will require further actions by the Italian Ministry of Health (“MOH”).
Immediately applicable provisions
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Role of the MOH
Firstly, the Decrees identify the MOH as the competent authority for implementing the Regulations and the Decrees and for monitoring and managing notified bodies. As a consequence, the Decrees grant to the MOH relevant administrative and regulatory powers, such as the power to: (i) designate and monitor the activities of notified bodies established in Italy; (ii) verify the information submitted by economic operators in the “Electronic System For Registration of Economic Operators” (i.e., a specific module of the European database EUDAMED established under section 30 of the MDR) and manage the National Database; (iii) carry out market surveillance activities, also through inspections, requests and controls to all economic operators and at their cost; (iv) restrict the access to the national market of medical devices (“MDs”) and in-vitro diagnostic medical devices (“IVDs”), also issuing withdraw or recall orders, in cases of breach of the provisions of the Regulations or the Decrees.
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Post-market surveillance on incidents and complaints
The Decrees replicate the Regulations’ provisions on manufacturers’ obligations to report serious incidents, field safety corrective actions, and the statistically significant increase in the frequency or severity of incidents other than serious incidents or unexpected, undesirable side effects in accordance with the timeframe and modalities established in sections 87 and 88 of the MDR and sections 82 and 83 of the IVDR.
On 10 October 2022, the MOH also approved a circular named “Guidance on surveillance activities under Articles 87, 88, 89 and 90 of EU Regulation 745/2017 and Article 10 of Legislative Decree No. 137 of August 5, 2022” (the “Circular”). The Circular is aimed at providing practical guidance to manufacturers, Healthcare Professionals (“HCPs”), lay users and patients, pending the full implementation of the EUDAMED platform.
Concerning manufacturers, the Circular fully replicates the provisions (including the timelines) of Articles 87 and 88 of the MDR, providing the templates to be used by manufacturers for various types of communications and the MOH’s office to which such communications must be addressed.
The Decrees and the Circular also provide additional responsibilities and prerogatives for other actors involved in post-market surveillance activities.
Mainly, HCPs (directly or through their Healthcare Organisation (“HCO”): (i) must report to the MOH and the manufacturer or its authorised representative (also through the distributor) any serious incident, even if only suspected, within ten days, as well as any complaint concerning a device; and (ii) must report to the manufacturer or its authorised representative (also through the distributor) and may report to the MOH any non-serious incident, preferably within 30 days.
Moreover, patients and lay users may report serious and non-serious incidents to the MOH and may decide to send the communication to the manufacturer or its authorised representative. The Circular specifies that patients and lay users may report said serious and non-serious incidents to their HCO/pharmacy/general practitioner of reference, who will, in turn, be required to make the necessary communications. Under the Decrees, patients and lay users may also send complaints to the manufacturer. The Circular specifies that said complaints may be sent to the manufacturer through the patient's HCO/pharmacy/general practitioner of reference.
In any event, all economic operators must inform the manufacturer once they receive a complaint or report from patients, lay users, or HCPs.
The Decrees mention that the terms and modalities for the above communication will be governed by subsequent implementing decrees, which will also govern the retention period of personal data collected by physicians, economic operators, and other actors during the reporting activities.
However, according to the illustrative report on the Decrees, this does not imply that the obligations are not already applicable. While awaiting the issuance of said implementing decrees and the full implementation of the National Device-Vigilance Network for communications by HCPs and HCOs, the Circular identifies the procedures to carry out the reporting activities of incidents and complaints.
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Derogatory authorisation and compassionate use
The Decrees allow the MOH, also upon request of regional health authorities, to authorise the commercialisation on the Italian market of MDs and IVDs that have not undergone or completed conformity assessment procedures. This is provided only in extraordinary cases of necessity and urgency and if the commercialisation of the MDs and IVDs is in the interest of public health or necessary to protect patients' health or safety. The derogation must have a limited time frame and may be subject to further restrictions or limitations.
Moreover, in extraordinary cases of necessity and urgency and in the absence of therapeutic alternatives, HCOs can request the MOH to authorise the treatment of single patients with MDs (but not IVDs) that have not already undergone or passed the conformity assessment procedures subject to the obtainment of the manufacturer’s declaration of commitment to provide the MD free of charge (compassionate use).
The legislative provisions foresee future implementing decrees concerning both procedures. However, since these instruments were also available under previous national legislation, it is reasonable to believe that the former procedures can still be used until the MOH implements new ones.
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Clinical investigations and performance studies
The Decrees replicate the provisions of the Regulations concerning clinical investigations (MDR) and performance studies (IVDR), providing – particularly for clinical investigations – detailed requirements on the technical and administrative aspects.
All clinical investigations must be, at least, communicated to the MOH and approved by an ethics committee. Class III and invasive class IIa and IIb devices require the favourable opinion of the ethics committee and express approval by the MOH, which should be issued within 45 days from the validation of the application. On the other hand, class I and non-invasive class IIa and IIb devices only need the favourable opinion of the ethics committee and mere communication to the MOH. In these cases, the clinical investigation may begin 30 days after the validation of the communication.
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Commercialisation and advertisement
The Decrees expressly allow for the online sale of all medical MDs and IVDs, without prejudice to restrictions that are in place or may be introduced with regard to the actors authorised to the sale of specific types of MDs and IVDs.
Moreover, the Decrees specify that information and indications relating to any type of MDs and IVDs, provided in writing by the manufacturer to the user and/or to the patient shall be expressed in the Italian language upon delivery to the end user, for professional use or for any other use.
The Decrees also confirm the previous advertisement regime, prohibiting advertisement to the public for: (i) custom-made devices; (ii) devices that require a medical prescription; (iii) devices that, according to the law or the manufacturer’s instructions, require the assistance of a physician to be used. In all other cases of advertisement to the public, prior authorisation of the MOH is required, in contrast to advertising to HCPs.
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Sanctions
The Decrees also establish a sanctions package that covers breaches of the same Decrees and the Regulations, significantly increasing the number of sanctions and their amount compared to previous national legislation. Sanctions’ amount may reach Euro 150,000, and, while the manufacturer is the most “exposed” subject, sanctions are also provided for other economic operators and for the Person Responsible for Regulatory Compliance (a function to be present in all manufacturers’ organisations according to MDR and IVDR), if its obligations under the Regulations are breached.
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Transitory regime under currently applicable legislation
Lastly, the Decrees explicitly refer to transitory provisions established in the Regulations.
Among others, reference is made to Article 120 of the MDR and Article 110 of the IVDR, which establish the transitory regime for MDs and IVDs.
With regard to MDs, those certified under the MDDs can be placed on the market until 26 May 2024, provided that as of 26 May 2021 i) they continue to comply with the relevant MDD and provided ii) there are no significant changes in the design and intended purpose. However, the requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, and registration of economic operators and of devices shall apply in place of the corresponding requirements in the MDDs. Such MDs certified under the Directives already placed on the market as of 26 May 2024, may still be made available or put into service until 26 May 2025 (so-called “sell-off provision”).
IVDs, on the other hand, have a different transitory regime with regard to deadlines, which has been amended by Regulation (EU) 2022/112 of 25 January 2022. In a nutshell, the principles mentioned above for MDs still apply but the deadline by which IVDs certified under the IVD can be placed on the market and the deadline by which IVDs already placed on the market can still be made available or put into service varies according to the (risk) class of device. Class D devices may be placed on the market until 26 May 2025, Class C devices until 26 May 2026 and Class B devices and Class A sterile devices until 26 May 2027. Devices may be made available or put into service for an additional year after these dates.
Recent developments on EU level to facilitate transition to MDR/IVDR
Regarding the necessary transition of MDs and IVDs from the Directives to the new framework under the MDR and IVDR, concerns and complaints have been raised from Italian industry associations, among others, on the severe risk of not being able to have MDs and IVDs certified on time, fearing that many products will at least temporarily exit the market. The main challenges concern the time and cost of certification, provided that the number of notified bodies is not yet adequate for the number of products to be certified under the Regulations.
Legislative measures to address these concerns were announced on EU level in a meeting of the EPSCO Health Council in December 2022.
To bridge the gap until these legislative changes will take effect, the Medical Device Coordination Group issued a Position Paper (MDCG 2022-18). The Position Paper aims to provide a uniform approach to the application of Article 97 of the MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate. According to Article 97 of the MDR, if a competent authority detects that a medical device is not compliant with the MDR but the device does not present an unacceptable risk to health or safety, it can require the economic operator to bring the non-compliance concerned to an end within a specific time instead of adopting immediately more restrictive measures (e.g., restrict or prohibit the product being made available on the market).
According to the Position Paper, Article 97 may allow competent authorities to authorise manufacturers to place safe devices on the EU market – for a limited period of time (regularly up to 12 months) - even without a valid certificate. To such end, the Position Paper details the conditions and the procedure under which manufacturers may proactively request, and obtain, the application of Article 97 of the MDR by competent authorities.
On 6 January 2023 the European Commission adopted a proposal for a Regulation which, if approved, will amend the MDR and the IVDR to address the serious risk of shortages of medical devices in the EU. According to the proposal:
- The transition period envisaged in the MDR is extended from the current date (26 May 2024) to 31 December 2027 for higher-risk devices and to 31 December 2028 for medium and low-risk devices. The validity of the associated MDD/AIMDD certificates is extended accordingly;
- The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR requirements will benefit from the additional time;
- A transition period until 26 May 2026 also for class III implantable custom-made devices will be introduced;
- The so-called “sell-off provision” will be removed from both the MDR and the IVDR, to prevent safe medical devices which are already on the market from having to be discarded. Notified body surveillance responsibilities during the transition period are clarified.
After a short public consultation of one week and an accelerated co-decision procedure of European Parliament and the Council the amendment will enter into force with its publication and be directly applicable in all Member States.
Non-immediately applicable provisions
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“Adapters” and adaptable medical devices
Legislative Decree no. 137/2022 delegates the MOH to adopt specific guidelines governing the activity of “adapters” on adaptable medical devices. The Regulations and corresponding Guidance 2021-3 of the Medical Device Coordination Group (“Questions and Answers on Custom-Made Devices”) only mention adaptable medical devices and refer to a definition of the International Medical Device Regulators Forum (“IMDRF”). Adapters could instead benefit from dedicated provisions.
Adaptable medical devices are mass-produced medical devices that must be adapted, adjusted, assembled, or shaped at the point of care (e.g., specific spectacle frames, optical glasses, hearing aids). According to the Regulations, a person who adapts, adjusts, assembles, or shapes an adaptable medical device for a particular patient (adapter) is not regarded as a manufacturer as long as the adaptation, adjustment, assembly, and shaping does not modify the device in such a way that compliance with the applicable requirements may be affected or the intended purpose is changed (Article 16(1) c), second subparagraph of the MDR).
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Clinical investigations and performance studies
Although the provisions mentioned above on clinical investigations and performance studies are immediately fully applicable (relevant sections of previous legislation have been abrogated with no transitory regime), the Decrees entrust the MOH with the power to adopt further implementing decrees, envisaging: (i) the procedures for submitting the application, its validation, assessment, and authorisation; (ii) the procedures related to the communications to be carried out by the sponsor; (iii) the provisions to avoid conflict of interests in the actors involved in the validation, assessment and authorisation process; and (iv) the requirements of the suitable facilities for the performance of clinical investigations.
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Advertisement
According to the Decrees, the MOH may adopt provisions derogating from the standard advertisement regime (i.e., i) extend advertisement prohibition to other MDs and IVDs and ii) identify MDs and IVDs the advertisement of which does not require authorisation).
Moreover, the MOH may adopt new guidelines (some have already been adopted in recent years) on the advertisement of MDs and IVDs, both to the public (when allowed, subject to prior authorisation) and to HCPs. In this regard, it will be interesting to see if the MOH will adopt an official stance on whether the online sale necessarily constitutes an advertisement, de facto preventing the online sale of MDs and IVDs that cannot be advertised to the public.
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EUDAMED and National Database for MDs and IVDs
The Decrees refer to the Regulations’ obligations regarding the EUDAMED platform (which, to date, is still not completely functional). The Decrees provide that, from the publication of the notice of full functionality of EUDAMED (mentioned in Article 34 of MDR) and until the date of abrogation of previous legislation, companies are allowed to use the old procedures and guidelines for the obligations established by the Regulations concerning market surveillance, registration of MDs and IVDs and economic operators, clinical trials/performance studies, and notification of certificates.
The Decrees also grant to the MOH the power to verify the information uploaded by economic operators as well as the power to issue the single registration number (“SRN”). Moreover, the MOH may charge economic operators a fee for the services rendered in relation to the platform.
The Decrees introduce the obligation for distributors of MDs and IVDs, operating in the Italian territory, to also register within the National Database operated by the MOH. This obligation, however, cannot be considered immediately applicable because, on one hand, the Decrees provide that the MOH will adopt further decrees to regulate how distributors should upload the required information and, on the other hand, previous legislation on registration within the National Database – which does not include distributors – will only be repealed following 24 months after publication of EUDAMED’s full functionality notice.
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Fund for the management of MDs and IVDs
The Decrees establish a new government fund for the management of MDs and IVDs (“Fondo per il Governo dei dispositivi medici”). Companies who manufacture or commercialise MDs and IVDs will have to contribute to the fund in a quota equal to 0.75% of their annual turnover related to the sale to the Italian National Health Service (“NHS”) of MDs and IVDs.
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Health Technology Assessment and economic governance of MDs and IVDs
The Decrees grant the MOH the power to adopt a national Health Technology Assessment (“HTA”) Plan within 180 days of the Decrees’ entry into force. The HTA Plan, which, to date, has not yet been adopted, will not only guarantee coordination and uniformity between different NHS entities in the acquisition and use of MDs and IVDs, but it will likely also introduce “specific classifications and conditions of purchase at the expenses of the NHS for the use of devices following their commercialisation”.
The HTA Plan will be functional to the national governance of MDs and IVDs, which is aimed at managing supply and demand for devices. HTAs can provide helpful information to reduce waste, optimise return on investment and seek the best value in technology acquisition. HTAs may include early recognition of innovation and evaluation of additional clinical care value. The HTA process must therefore direct the assessment towards technologies of most significant interest, i.e., innovative, with a high and positive clinical, economic, organisational, and care impact.
This provision is quite interesting since it seems to display the trend of an increasing structuring of MDs’ and IVDs’ governance, which may become at least similar to the medicinal products’ “model”, characterized by: HTAs, reimbursement procedures and related classes of reimbursement, advantages for innovative products, and pay-back mechanisms if the budget of the NHS is exceeded.
With regard to the HTAs, it is worth noting that some Italian Regions are starting to develop systems that give relevance to the HTAs, at least in terms of “fast track” market access procedures. For example, Tuscany’s Regional Resolution no. 737/2022 has established a fast track for purchasing innovative devices by NHS entities. Therefore, such devices will be made available to clinicians and patients much faster than after traditional tendering procedures. This fast track procurement procedure must rely upon a prior HTA, carried out on the basis of the innovativeness parameters established by the Region itself.
Also, industry associations are calling for an MDs’ and IVDs’ governance system that would incentivise companies to invest in research and production of innovative devices. This would lead to added value for the patient or more economically sustainable processes, but also to more significant burdens and costs for manufacturing companies. Nevertheless, the Italian government has decided to apply the pay-back mechanism (making the companies bear the cost of expenditure cap overruns) instead of supporting the manufacturing companies in the innovation process.
It should be noted that, while the pay-back mechanism was introduced in Italy already in 2015, it was only on 15 September 2022 that the MOH published in the Official Gazette its first ministerial decree on the subject, certifying the exceeding cap for years 2015, 2016, 2017 and 2018. Consequently, companies will have to pay back to Regions Euro 416,274,918 for 2015, Euro 473,793,126 for 2016, Euro 552,550,000 for 2017, and Euro 643,322,535 for 2018. According to Law Decree no. 115/2022, Regions will publish, by 15 December 2022, the list of companies subject to the pay-back obligation, which were originally supposed to proceed with the payment within the following 30 days. However, also in light of the industry's opposition and the hundreds of appeals raised by supplying companies before the Italian administrative courts, in January 2023 the Italian Government postponed the deadline for the payments to Regions to 30 April 2023. In addition, it is possible that the Government will use this timeframe to take into consideration a wider review of the mechanism (e.g. an amendment of the spending caps or a review of the criteria used for assessing the amounts due).
The Decrees also introduce other provisions which are relevant in terms of the governance of MDs and IVDs. Within 90 days from the entry into force of the Decrees, the MOH should have officially constituted and regulated the functioning of the National Observatory on Medical Device Prices (Osservatorio Nazionale sui prezzi dei dispositivi medici), which should have the task of supporting NHS entities and verifying the consistency between purchase prices of MDs and IVDs and the reference prices defined by the Italian Anticorruption Authority. However, this cannot be done by resorting to additional budgeting, as the Decrees specify that no new or increased burdens on public finance are to result from the implementation of these Decrees. The administrations concerned shall, in fact, carry out the activities provided by the present Decrees with the only resources available under the legislation in force. To date, the National Observatory on Medical Device Prices has not yet been officially constituted.
Next steps
The Decrees set forth provisions – both immediately and non-immediately applicable - which companies must consider when carrying out and potentially adjusting their business operations. Notably, in light of the above analysis, companies:
- Should get prepared to comply with the upcoming obligation for distributors of MDs and IVDs operating in the Italian territory to register within the National Database, also by monitoring the adoption by the MoH of future decrees that will regulate how distributors should upload the required information;
- Before proceeding with the online sale of MDs and IVDs, should verify the existence of any specific regulations restricting the trade/advertisement of that category of devices;
- Should update and adapt existing policies and procedures (and, if necessary, adopt new ones) to comply with the new requirements of the Regulations and Decrees, mitigating the risk of sanctions;
Should monitor any measure, including at the European level, that may affect the transitional provisions and timelines for the placement on the market of MDs and IVDs certified under the Directives and for the validity of said certificates.
Authored by Giuseppe Aminzade, Fabien Roy, and Angelo Forte.
