Fundaments of the EU-MDR
The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.
Implementing the EU-MDR requires a structural approach since the transition to the EU-MDR CE certificates can last over several years.
Do you need to know more than the basics of the MDR? Our 2-day course has been designed to introduce medical device manufacturers to the key changes in the requirements for CE Marking.
Duration: 2 days
- Medical Device Regulation and the Approach
- Legal and operational structure
- Scope & Definitions
- Placing CE marked product on the market
- EUDAMED & UDI
- Notified Bodies
- Classification and Conformity Assessment
- Clinical Evaluation & Investigations
- PMS & Vigilance
- Annex 1 until 17.
- Understand the Medical Device Regulations
approach in Europe
- Understand the structure and purpose of the
Medical Device Directives
- Explain the use of Essential requirements,
including the use of (harmonized) Standards
- Apply the Classification Criteria and
- Identify the conformity assessment routes
- Identify Technical Documentation
- Importance and Role of Clinical Data
- Identify the importance and contents of Post
Who should attend?
Medical device manufacturers, especially if your role is in:
- Regulatory Affairs
- Design and Development
- Clinical Affairs
- Quality Management
- Quality Assurance
- Internal and External Auditors.
There is no prerequisite for this course but participants will benefit from a basic knowledge of the Medical Device Regulations in Europe.
Costs: - € 875.- p/p for a one-day training
- €1350,- p/p for a two-day training
We offer open enrolment, on-location, train-the-trainer formats.
Please contact us
to schedule in-house training
, which is also recommended for training multiple colleagues or teams at the same time.