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Fin dall’entrata in piena applicazione del MDR, uno dei punti più discussi è stato l’approccio uniforme richiesto a tutte le tecnologie, indipendentemente dal loro livello di innovazione. In pratica, anche dispositivi con decenni di utilizzo clinico e un profilo di sicurezza ben noto si sono trovati a dover soddisfare requisiti documentali e clinici comparabili a quelli di tecnologie completamente nuove. L’aggiornamento WET va esattamente nella direzione opposta: introduce un approccio più proporzionato, riconoscendo che non tutte le tecnologie partono dallo stesso livello di evidenza e conoscenza. EU_notizie false
31 March 2026

MDR WET UPDATE

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MDR WET Update (March 2026)

The European Commission has adopted a new Delegated Regulation intervening on the MDR (Regulation (EU) 2017/745) with a specific focus on so-called Well-Established Technologies (WET).

Since the MDR became fully applicable, one of the most discussed points has been the uniform approach required of all technologies, regardless of their level of innovation. In practice, even devices with decades of clinical use and a well-established safety profile have found themselves having to meet documentation and clinical requirements comparable to those of completely new technologies. The WET update goes in exactly the opposite direction: it introduces a more proportionate approach, recognising that not all technologies start from the same level of evidence and knowledge.

What 'Well-Established Technology' really means

The Delegated Regulation seeks to clarify what'well established technology'means:

  • an established clinical history with widespread and documented use
  • a stable and predictable risk profile over time
  • the availability of extensive and consistent scientific literature
  • sufficient post-market data to confirm safety and performance

A look at clinical evaluation

With the WET update, the principle that, for established technologies, greater reliance can be placed on existing data is reinforced. In practical terms, this translates into greater use of scientific literature and historical data, data from PMS and PMCF, and review, in justified cases, of the need for new clinical investigations.

How long does the implementation of a Delegated Regulationtake ?

To understand the context of this update and when and in what final form it will be adopted, it is useful to recall how the process of adopting a Delegated Regulation works in the European Union. The process follows a few key steps

  1. a formal delegation provided for in the basic regulation
  2. a technical preparation phase, involving experts and stakeholders
  3. formal adoption by the Commission
  4. a period of scrutiny by Parliament and the Council
  5. publication in the Official Journal and entry into force

Overall, a total time between 9 and 18 months can be estimated, from the preparatory phase to actual implementation.

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