MedTech SPIN Webinar: EU-MDR New Rule 21

MedTech SPIN Webinar: EU-MDR New Rule 21
In this webinar, Theresa Jeary will shed some light on rule 21, its intent and how manufacturers can develop an effective regulatory strategy to successfully navigate conformity assessments and ensure Annex I to Directive 2001/83/EC requirements are met.

Date: Tuesday 14 February 2023
Time: 14:00-15:00 GMT /15:00-16:00 CET

The EU-MDR new rule 21 applies to all substance-based medical devices. Impacted manufacturers are seeing their products up classified to Class IIb shifting their regulatory requirements, in some cases, from self-declared Class I to full conformity assessment procedures with notified body involvement. Additionally, impacted devices must provide pharmacokinetic studies, such as absorption and distribution, to meet the requirements set by Annex I to Directive 2001/83/EC as it relates to medicinal products for human use.

Our Guest Speaker:

Theresa Jeary holds a Master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland.

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 the new requirements of the Medical Device Regulation.  Theresa re-joined BSI in August 2020 working as a Technical Specialist in the Medicinal and Biologics Team.



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14/02/2023 14:00 - 15:00
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