The new MDR Regulation – Circular from the Ministry on November 12, 2021

On November 12, 2021, the Ministry of Health published the important explanatory circular (no. 0081386) regarding the correct application of the new MDR Regulation 2017/745.

The most relevant aspects include:

Confirmation that new requirements for post-market surveillance must be applied to all medical devices. Indication that all Class I devices certified in accordance with Directive 93/42/EC, which do not undergo a different classification under Regulation 2017/745, must comply with the new regulation immediately without exceptions. The derogation valid until 2024 applies exclusively to those Class I devices certified according to Directive 93/42/EC that undergo a different classification under the new MDR regulation. At the moment, the derogation from the application of the new regulation is confirmed for all products similar to medical devices listed in Annex XVI of the new MDR Regulation 2017/745, deferring the obligation to apply from the publication of common specifications, to be adopted with an implementing act of the European Commission. The drafting of common specifications is currently being defined and will contain general principles to follow and specific provisions regarding transition times for products already on the market. AP Engineering, with its staff having certified expertise, is capable of supporting you in this important certification update process by providing all the necessary support.