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IVD regulatory framework

On September 26, 2012 the EU Commission released its proposal for future regulation of medical devices. Within the package, the current three Directives on active implantable medical devices(AIMD), medical devices (MDD)as well as in vitro diagnostic medical devices(IVDD) are replaced by two Regulations, one covering all medical devices, the other covering IVDs.

These new rules are proposed for a number of reasons, including the need to bring legislation in line with the pace of technological and scientific progress over the last twenty years. In addition the proposed changes bring uniformity as current Directives lead to different interpretation and implementation in the various EU member states and consequently to different levels of patient and public health protection in the EU. The new Regulations also aim to improve traceability, and transparency.

This webinar will cover:

  • The proposed new IVD Regulation, specifically focussing on areas of potential significant impact.
  • In particular, re-classification of IVD devices and proposals for Clinical Evidence
  • We will touch upon what can be done now to prepare for change!


Sue Spencerhas 28 years experience in the IVD industry, and has held positions in R&D, Manufacturing and Quality Assurance.

Erica Conway has 12 years experience in the IVD and pharmaceutical industries, within Regulatory Affairs. Erica joined BSI in their IVD team at the beginning of 2014.