Clinical Evaluation Guideline and Regulation for Medical Devices in the EU

This course provides an in-depth overview of how medical devices reach the market, focusing on regulatory bodies, conformity assessments, and key terminologies. It covers the clinical evaluation process under EU MDR 2017/745, detailing the stages of clinical evaluation, the role of clinical evaluators, and key principles. Additionally, it discusses guidelines and EU regulations pertinent to clinical evaluations and medical device classifications.

Module 1 : How Does the Medical Device Reach the Market?

  • What is Notified Body (NB)?
  • What is CE (Conformity Assessment)?
  • Role of European Medicines Agency (EMA) for Medical Device
  • Medical Device Coordination Group
  • National Implant Registry
  • Introduction to Medical Device
  • Active Medical Device
  • Placing on the Market
  • Adverse and Serious Adverse Event
  • Key Terminologies related to Action Taken By Medical Device’s Manufacturing Regulatory Body
  • Harmonized Standards
  • Purpose of ISO 14155:2011
  • MDCG (Medical Device Coordination Group)

Module 2 : Clinical Evaluation of Medical Devices under EU MDR 2017/745

  • MDR (Medical Device Regulation) 2017/745
  • Definition of Clinical Data and Clinical Evaluation
  • Qualification of Clinical Evaluator
  • Clinical Evaluation Process

– Stage 0 : Scope and Plan

– Stage 1 : Data Identification

– Stage 2 : Data Appraisal

– Stage 3 : Data Analysis

– Stage 4 : CER (Clinical Evaluation Report)

  • Clinical Evaluation: Key Principles

Module 3 : Clinical Evaluation Guidelines and EU Regulations

  • MEDDEV 2.711
  • Literature Search and Review
  • Purpose of EU (European Union) Medical Device Regulation
  • Amended MDR (Medical Device Regulation)
  • GMDN (Global Medical Device Nomenclature) Agency User Guide Generic Devices

Certificate In FCPM [ Online ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play
Get to work on live projects
Face-to-face guidance by PM
Clinical on-site exposure