EC Adds IMQ as Fourth Notified Body Designated Under MDR

Regulatory NewsRegulatory News | 20 August 2019 |  By 

The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR).

The announcement does not come as a surprise, as Italy’s Ministry of Health announced in late July that IMQ met the requirements of the regulation. The EC had also previously indicated in its rolling plan, updated last Monday, that four NBs have been designated.

The other three NBs to be designated are: BSI UK, Germany-based TÜV SÜD and Germany-based Dekra Certification GmbH.

But with 52 applications received by the EC and 33 joint assessments carried out, onlookers are still trying to figure out which NB will be notified or drop out next. Several NBs have declined to seek designation under MDR/IVDR already, including London-based Lloyd's Register Quality Assurance (LRQA) and Swiss NB QS Zürich AG.


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