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Regulatory Compliance

Regulatory compliance Medical devices include a very wide array of products, ranging from a simple bandage to life maintaining active implantable devices such as heart pacemakers. In order to ensure the safety and effectiveness of these devices, they are classified according to the risk factor and thus have different regulatory approval processes. For the lowest class devices, such as Class I non-sterile, the manufacturer may self-certify; in the example of the heart pacemaker, the manufacturer needs to submit an extensive dossier of information to be examined by the notified body who will then decide if the device may be placed on the market.

Different regions have varying regulations with regards the placement of medical devices on the market, and have different classification methods. In the EU, devices need to have a CE mark. In the US, devices need to be FDA approved. All regions have their own regulations, sometimes following along with the EU or FDA system, but may have regional variations.

The route to approval or “regulatory pathway” needs to be considered in the very early stages of device design. As this can be a complex process, with adverse consequences if the device is not classified correctly or the incorrect route to conformity is selected, it is important to engage the services of an expert who has prior experience with the type of medical device you plan to develop.

Meet Marie Rooney, Regulatory Consultant

Marie Rooney is an independent regulatory consultant in Medical Device and Diagnostic areas with a track record of success in both EU and FDA regulatory environments from concept through to commercialisation e.g. ISO System design and implementation, design control systems implementation, sterilisation validation, CE marking, Technical file preparation, literary reviews for clinical evaluations etc.

Marie has 20 years of general management experience in the healthcare industry with particular experience in diagnostics. Ms Rooney was Operations Manager with Trinity Biotech Plc, an Irish headquartered diagnostics company. Previously, Marie was an R&D scientist with Cambridge Diagnostics Ltd., a wholly owned subsidiary of Inverness Medical Innovations Inc. Marie is a graduate of the University of Limerick and holds a Master’s degree in Project Management.

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