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
Course Content
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
Course Provider
Ms 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.
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
