Medical Device Regulation Finally Published

August 1, 2016

The consolidated final draft of the new Medical Device Regulation (MDR) has recently been published. The new regulation shall replace the current medical device directives, namely Medical Device Directive 93/42/EEC and Active Implantable Medical Devices 90/385/EEC.

 

The IVD Directive 98/79/EC will be replaced by its own new regulation, named the In Vitro Diagnostic Medical Devices Regulation, IVDR.

 

This new regulation on medical devices will bring forth many change for medical device manufacturers. Apart from changes to the classification of some medical devices, the definition of medical devices is also expanded. The definition of medical devices is expanded to include, amongst others, devices with purposes related to prediction and prognosis of diseases. This change might have an impact on quantification products and services in the field of health-related parameters which could now fall within the scope of the new Regulations.  For certain high-risk devices, such as implants, products may now undergo an additional check by experts before they are placed on the market. The conformity assessment procedure for these devices can include the intervention of expert panels, designated by the European Commission. Notified bodies may seek advice from an expert panel on applications for conformity assessment for such devices. The notified body shall give due consideration to the views expressed by the expert panel.

 

Although the final draft is expected to be adopted by the end of this year, the new law will come into effect three years after publication in the EU Official Journal.

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