Italian Ministry of Health published a new document on medical device governance

In late March 2019, the Italian Ministry of Health has published a new document on medical device governance. The document has been prepared by the Technical Committee for Pharmaceuticals and Medical Devices, established by the Ministry of Health in August 2018.

Already in place for pharmaceuticals, this document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices.

The governance aims to address critical issues:

• A sector in strong expansion, with a high intensity of renewal and increasing technological complexity, not always easily ascribable to a real impact in terms of better care results for patients
• A European regulation that does not bind the authorization to the market of medical devices to the presentation of adequate scientific evidence of safety and clinical efficacy
• The responsibility of Member States to oversee safety and implement tools for innovation sustainability
• A health system where the supply of technologies dominates the mechanisms of choice, which should instead start from the real demand for the health of citizens

The aims of the document are:

• To base decisions on the needs of patients and on the added value of technology, demonstrated in terms of results
• Assume calculated risks and only in the presence of highly significant potential benefits
• Make the monitoring of risks and benefits efficient
• Communicate to the industry the safety and comparative effectiveness requirements necessary to propose innovative products

Considering the responsibilities that European legislation places on the Member States with regard to supervision, safety evaluation, effectiveness, comparative analysis of clinical benefit and sustainability for their national health service, the medical devices governance aims to achieve its objectives through the following actions:

• Optimization of governance activities, through strategic coordination of the collaborations now entrusted to different bodies and the regulation of relations with the representatives of the DM sector
  • Strategic coordination and overcoming current overlaps and fragmentation of competences
  • Regulation of information, training and collaboration activities in the use of DMs
• Spending governance through efficient purchasing processes that are functional to the expansion of a competitive market and the ensuing recovery of resources to be allocated to innovation
  • Reorganization of the classification system of medical devices
  • Definition of homogeneous product clusters
  • Establishing reference prices, the observatory of consumption, contracts, and prices
  • Boost to the competitive market
  • Medical devices to enter the NHS
  • Enhance the role of spending limits
• Strengthening the surveillance and safety control system
  • Implement traceability of implantable medical devices
  • Utilize registries, usage analysis, and performance of implantable medical devices
  • Surveillance of the market and serious adverse events
• Governance of the demand and supply of medical devices, through the early recognition of innovation and the evaluation of the additional clinical care value of innovative medical devices
  • HTA National Program of Medical Devices
  • medical devices declared "innovative" to enter the NHS
  • Horizon scanning activities
  • HTA of large equipment
  • Decision-making processes informed by HTA reports
  • Post-marketing research and controlled introduction of high-risk innovative medical devices
  • Involvement of medical device users (patients and professionals)

See the full news in Italian here.

See the governance document in Italian here.

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