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Led by Theresa Jeary, this session shall provide an overview of the Regulatory Classification of Health Products and examine the borederline area between medical devices and medicinal products detailing key considerations in product development and regulatory strategies. 

Theresa holds a Master's degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and has over 30 years' experience working in both the Pharmaceutical and Medical Device industries. 

In addition to her product development and regulatory expertise, Theresa has over 14 years Notified Body experience, having worked for both LRQA, where she held the role of Head of Notified Body, and BSI, working as a technical specialist in the Medicinal and Biologics team, having responsibility for devices with ancillary medicinal substances, device classification decisions and Article 117 NB opinions. 

Theresa is a regular presenter on MDR Implementation and contributes to various scientific publications, as well as regulatory guidance documents. She has extensive experience interacting with EU Competent Authorities.