The regulatory environment for medical devices is in a transitional period. With the increased focus on patient safety, the MDR has introduced many changes to the requirements and processes involved.
Designed for professionals with a working knowledge of medical device regulatory affairs, this course will provide essential guidance on how to successfully transfer products from the current regulatory system under the Medical Device Directive (MDD) to the new MDR.
Regulatory strategy and life cycle management will be a key focus of the programme with comprehensive sessions on regulatory pathways, technical documentation, clinical evaluations and investigations. There will also be a review of the requirements for the vigilance system, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies.
Delegates will cement the knowledge gained through case studies and practical workshops and there will be ample opportunity to discuss the complexities involved with two medical device experts, both of whom have huge knowledge and experience in this field.
Key Topics Covered:
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
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
Source: https://www.businesswire.com/
