Course Details

Overview

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.

Key takeaways and learning objectives

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.

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.