The proposed EU regulations for medical and in vitro diagnostic devices

An overview of the likely outcomes and the consequences for the market

The proposals for the new Medical Devices Regulations (MDR) and In Vitro Diagnostic Devices Regulations (IVDR) will provide a new regulatory framework for medical devices in the EU for the coming decades. The proposals were revised following a political move for more centralized and pre-market controls on higher risk medical devices.

The proposals for the new MDR and IVDR started out as a modest mid-life update to the existing directives.

However, they were significantly amended following an additional impact assessment related to several highly publicized issues with medical devices in the EU market that sparked a political wish for more centralized and pre-market controls on higher risk medical devices.

This white paper discusses the most important items in this revision as per the state of the legislative proposals in April 2014.

Although crucial elements of the regulations are still subject to political debate, one thing is clear: the regulations will cause important changes for all companies in the field.

Companies need to prepare to deal with these changes in a pro-active and timely manner to avoid having certificates suspended or revoked because they were unable to comply with the new legislation in time.

BSI 2015

Proposal for a Regulation of the european parliament and of the council on medical devices

Proposal for a regulation of the european parliament and of the council on in vitro diagnostic medical devices