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
Duration : 4hrs / week ( 2 days/week )
Schedule : Session of 2 hours twice a week
Batches Starting From
August 2024
Enroll Now For Early Bird Offers
Duration : 4hrs / 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 (Project Manager)
Clinical on-site exposure