Date: 3 October 2023

What is the webinar about?

The EU-MDR Rule 21 applies to all substance-based medical devices and is a new rule for medical devices.  The principal mode of action for Rule 21 devices is by physical or simple chemical means and they are presented in a dosage form usually associated with a medicinal product, such as a liquid, cream, tablet, or capsule.  Historically, many such devices have been regulated as medicinal products, but the MDR now allows for the acceptance of physically acting products that are ingested, applied to the skin or a body orifice as a medical device.

Join us for this insightful webinar, presented by Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics Team, BSI, as she explores in-depth on Rule 21, its intent and focus on the borderline nature with medicinal products. She will also explore the key aspects that manufacturers need to consider when developing an effective regulatory strategy to successfully navigate conformity assessments and ensure Annex I to Directive 2001/83/EC requirements are met.

Who should attend?

Regulatory professionals working as manufacturers of substance based medical devices, as well as consumer health product manufacturers and pharmaceutical companies.

What will participants gain?

Participants will gain an appreciation of the background to the inclusion of this new rule in the MDR and gain an understanding of expectations for the Conformity Assessment process.

Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early-stage development, process transfer, validation, and regulatory departments.

In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.

More recently, Theresa has worked as a consultant to the MedTech sector assisting manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations.

Theresa re-joined BSI in August 2020, and is a principal technical specialist in the Medicinal and Biologics Team.

Theresa is the chair of the Team-NB Working Group for Rule 21 Devices, she regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.