NIA Meeting Report: Medical Devices: Is the new legislation sufficient to protect patients?

Following the publication of the proposals of the European Commission for two regulations on medical devices and on in vitro medical devices, the Alliance of Liberals and Democrats for Europe (ALDE) held a meeting at the European Parliament to discuss shareholder's views on the topic.

The proposal for a recast of the medical devices regulation contains elements relating to nanomaterials and aims at classifying devices incorporating or consisting of them as class III products. Nanomaterials were unfortunately not addressed at the meeting; however, as explained by the representative from the Commission, class III devices will be subject to extended control and manufacturers will have to provide significant information about the safety of their products.

Follow this link for the NIA Meeting Report.

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