Medical Devices Advanced Regulatory Affairs Training Course | Practical MDR Life Cycle Management Skills for Successful Product Transition (ONLINE EVENT: October 2-3, 2025) - ResearchAndMarkets.com

By: Research and Markets via Business Wire

August 18, 2025 at 08:17 AM EDT

The "Advanced Regulatory Affairs for Medical Devices Training Course" training has been added to ResearchAndMarkets.com's offering.

Explore the MDR's updates enhancing patient safety and understand its revised requirements and processes to navigate the evolving regulatory environment effectively.

This course is crucial for professionals already versed in medical device regulatory affairs, offering indispensable guidance on transitioning products from the current Medical Device Directive (MDD) framework to the new Medical Device Regulation (MDR).

Emphasizing regulatory strategy and lifecycle management, the program includes in-depth sessions on regulatory pathways, technical documentation, clinical evaluations, and investigations. Participants will also delve into requirements for the vigilance system, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) studies.

Through interactive case studies and practical workshops, delegates will solidify their knowledge and engage in discussions with two experienced medical device experts, navigating the complexities of regulatory compliance effectively.

Certifications:

CPD: 12 hours for your records
Certificate of completion

Who Should Attend:

This course will provide experienced medical device professionals with the practical regulatory knowledge to apply life cycle management in an MDR environment, particularly those who play a key role in transitioning their products to the MDR, including:

Medical device regulatory affairs professionals
Vigilance and PMS managers
Clinical evaluation/investigation specialists
Project managers

Key Topics Covered:

Day 1

The impact of the MDR on your role and responsibility

Why a change in regulation?
Structure of the new regulation and flow of compliance
Key analysis of the changes
Changes to roles and responsibilities of key stakeholders
Competent authorities and Notified Bodies
Economic operators - role and responsibilities
Person responsible for regulatory compliance

Borderlines and classification

Borderline determination
Software qualification and classification
Understanding the classification process
Investigating the classification rules (emphasis on the new rules)

Classification workshop: Practical session on applying the new rules

GSPRs Annex I requirements

Requirements for clinical evaluations and investigations

Requirements, standards and guidance
Understanding the importance of clinical evaluation
Key requirements of clinical investigations

Clinical evaluation and investigation workshop: Consolidating the key requirements

Conformity assessment

Various conformity assessment routes
Scrutiny process and key considerations
Selection of and engagement with your Notified Body

Day 2

The new market surveillance tools

The European database (EUDAMED)
Unique device identification (UDI)
Supply chain surveillance and traceability

Requirements for PMS

Understanding PMS requirements
Implementing effective PMS

The new vigilance system

Management of adverse incidents
Definitions: what is reportable, the reporting process and investigation
Corrective action
Periodic safety update reports - how to manage this requirement

Vigilance workshop: Report or not to report?

PMCF studies

Requirements for PMCF
Types of PMCF

Future Evolution of the Medical Device Legislation

UKCA Marking

Speakers:

Theresa Jeary

Technical Manager for Medical Devices

Lloyds Register Quality Assurance (LRQA)

Theresa Jeary holds a Master's Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.

Theresa has over 25 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, and has been a part of the team for many commercially available medicinal and medical device products.

Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.

Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the "fence" and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).

Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.

At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.

For more information about this training visit https://www.researchandmarkets.com/r/i7apmu

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View source version on businesswire.com: https://www.businesswire.com/news/home/20250818663742/en/

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Medical Devices Advanced Regulatory Affairs Training Course | Practical MDR Life Cycle Management Skills for Successful Product Transition (ONLINE EVENT: October 2-3, 2025) - ResearchAndMarkets.com

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