Authorized Representative Services

Products without an intended medical purpose!

The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.

The transitional provision are explained in Article 2 and 3. Some provisions will enter into force on 22 December 2022. Here you can find the whole document.

The provisions in this document may provide a taste for the new transition of all other legacy products discussed here last week. If we apply this, then certificates may safely expire, however, a Notified Body will need to be engaged for surveillance activities. This can be your current MDD Notified Body or your new MDR Notified Body. 

Can this be even more complicated?? In any case, we are just curious about the cut-off date. 

An early date would be good for many manufacturers, however, it may already be too late for some other manufactures who stopped their products and disengaged from a Notified Body.   

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