Italy: Medical devices, published the Guidance MDCG 2022-4 & More News Here

In transient

On 16 February 2022, the Medical Device Coordination Group (MDCG) permitted a brand new doc (i.e., MDCG 2022-4) to supply steering to Notified Bodies on the applicable method to perform surveillance actions on CE-marked gadgets in accordance with the Medical Devices Directive 93/42/EEC (“MDD“) and the Active Implantable Medical Devices Directive 90/385/EEC (“AIMD“), which, by advantage of the provisions of Article 120(3) of Regulation EU 745/2014, will be marketed till 26 May 2024.

Key takeaways

  • In explicit, the doc gives detailed directions on surveillance actions that Notified Bodies are required to hold out to be able to evaluate the Quality Management System documentation, adopted by producers who proceed to make use of the market gadgets licensed in accordance with the aforementioned Directives.
  • In this regard, the doc specifies that Notified Bodies should confirm whether or not (i) the scope of gadgets lined by the MDD or the AIMD certificates stays, or if and which gadgets are discontinued; (ii) the producer has adjusted its Quality Management System in accordance with the necessities of Article 120(3) MDR regarding vital adjustments; and (iii) the producer has made the essential changes with respect to the Quality Management System on post-market surveillance, market surveillance, vigilance, and registration of financial operators and gadgets.
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