Understanding Clinical Evaluations and Post Market Clinical Follow Up

Module 1

Introduction to Clinical Evaluations

• Overview of medical device regulation in Europe
• Overview of relevant Directives and Guidance
• Impact of the Medical Device Regulation (MDR)
• Impact of MedDev 2.7.1 Rev 4
• Introduction to ISO 14791 – Risk Management for Medical Devices

Module 2: 

Clinical Evaluation Process

• Overview 5 key stages
• Finding the clinical data – clinical literature review
• Assessing the clinical data
• Analyse the clinical data
• Conformity with the Essential Requirements

Module 3: 

Clinical Evaluation Report (CER)

• Overview of the Clinical Evaluation Report (CER) content
• Who should write the CER?

Module 4: 

Clinical Evaluation Throughout the Product Lifecycle

• When to conduct a clinical evaluation
• Stage 1: Device development
• Stage 2: Initial CE-Marking equivalence
• Stage 3: Post market

Module 5 

Post Market Clinical Follow-Up

• Overview of relevant Directives and Guidance
• Post Market Surveillance – where does PMCF fit in?
• Why do we need PMCF?
• PMCF study design
• Implementing PMCF

Programme overview

The new MDR (Medical Device Regulation) 2017/745 has raised the bar on not just the requirements surrounding clinical evidence, but the level of examination now carried out  by notified bodies on Clinical Data.

The EU MDR is setting the framework for busy times ahead for medical device practitioners looking to meet the new higher bar requirements set out by the MDR and clinical evidence plays a big role in increased workload. The Frequency of updates to the Clinical Evaluation Report (CER)has changed. Qualifications of report authors and evaluators is now under scrutiny. You now must define Specific and measurable objectives for the CER and establish Scientific validity of data been presented to the notified body. Updates to CERs may also trigger updates to Instructions for Use; make sure they are in alignment. Clinical investigations must be conducted within the constructs of the new legislation   and recognized ethical principles.

Who is the course for

Medical Device practitioners who have to compile CER’s

Regulatory personnel who have to complete Technical Files for CE marked medical devices

Anyone who has an interest in CERS

Learning outcomes

Understand what is Clinical Evaluation and what are the Clinical Evaluation Guidance Documents

Understand Clinical Evaluation Requirements under new MDR

Understand Methodology employed to carry out CER

Understand the Requirements of Literature Search and Screening

Understand the Fundamentals of good medical writing

Greater understanding of layout of CER

Compliance to Post Market Clinical Follow up