Sponsored: Implementation of EU MDR Article 117

Sponsored: Implementation of EU MDR Article 117
FREE SPONSORED WEBINAR -   The Implementation of EU MDR Article 117 for integrated drug/device combinations and lessons learned – Industry and Notified Body perspectives.
Date:  12 October 2023
Time: 15:00 - 16.00 BST

The EU MDR 2017/745 Article 117 introduced requirements for device part of an integral drug-device combination to comply with applicable MDR Annex I requirements, so called GSPRs (General Safety and Performance Requirements). Compliance to GSPRs of higher risk class device parts such as pre-filled syringe, autoinjector, inhaler will require involvement of Notified Bodies to obtain a Notified Body Opinion (NBOp). An NBOp is an essential part of the marketing authorization dossier of a drug product.
 
This means that what may have previously been considered as a contain-closure of a medicinal product, now needs to be considered as if it were a medical device and technical documentation must be prepared and submitted to a Notified Body for review. This presents a challenge for the pharmaceutical industry who may lack medical device expertise and may not be familiar with the EU MDR and the GSPRs.
 
In this webinar, Pharmalex will explain the regulatory requirement and provide some key learnings from the first few years of experience with these types of submissions. We will also hear from a leading Notified Body expert to understand better NBOp submission process and related expectations, and to highlight some of the common issues they see with submissions for Notified Body Opinions.     
 
KEY LESSONS:
• The regulatory requirements
• Notified Body Opinion process and expectations for the technical documentation.
• Key challenges and lessons learned by Industry.
• Interactions with the EMA.

ABOUT THE SPEAKERS:


Tiina Riihimäki, PhD
Director, Head of Medical Devices / IVDs, Nordics, PharmaLex

Tiina holds a PhD degree on medical technology from the University of Tampere, Finland. Additionally, she is a graduate of University of Jyväskylä, Finland where she completed her M.Sc. (Chemistry) studies. 

Tiina has over 15 years, experience working in both the academy and in highly regulated medical device and diagnostics industry. She has versatile scientific, conformity assessment and industry background and has in-depth knowledge of various medical technologies, state-of-art methods as well as EU MD/IVD regulatory requirements, and quality management systems covering the entire life cycle of a medical device or combination drug-device. Tiina has over 5 years Notified Body experience containing various roles including lead auditor role and technical/medical assessor roles. Additionally, she has been working in the MDCG mirror working group as a Team-NB member.

Currently she is Heading the medical device /IVD business development and services at Pharmalex Nordics. 


Theresa Jeary
Principal Technical Specialist, Medicinal & Biologics,BSI

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 a regular presenter on combination products in the EU and 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.
 


Disclaimer
Whilst TOPRA is running this webinar for Pharmalex, this is not an endorsement of Pharmalex, Pharmalex's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

 
When
12/10/2023 15:00 - 16:00
Where
ONLINE
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