|Target Audience||Manufacturers, Authorised representatives, Importers, Distributors, Notified Bodies|
IVDR (EU) 2017/746
IVDR – Article 110
MDCG 2021-13 rev.1
This guide explains how to apply and interpret the article 110 §3 of Regulation (UE) 2017/746.
The 1st part specifies that the distinction between “legacy devices”, “old devices” and “IVDR devices” is established both according to the regulations with which the device complies (respectively: Directive 98/79/EC, ante Directive national regulations, Regulation (EU) 2017/746) and its period of placing on the market or putting into service. To fully understand the provisions, it should be borne in mind that the concept of placing on the market applies to each product individually and not to a type of product (see Blue Guide – §2.3 v 2016).
The 2nd part details the requirements of Regulation (EU) 2017/746 which are applicable for “legacy devices” and “old devices” which are limited according to article 110 §3 to aspects of post-market surveillance, market surveillance, vigilance and registration of economic operators and devices.
A table summarizing the requirements is provided at the end of the guide, do not hesitate to consult it!