Medical Device Regulation (MDR) Implementation
2 Days
A two day course providing details of the new MDR which replaces the existing MDD (Medical Device Directive 93/42/EEC) and AIMDD (Active Implantable Medical Device Directive 90/385/EEC). This course is primarily intended for enterprises who already manufacture products against the existing MDD. It can be delivered as either a public or in-house event but is seen as particularly attractive as in-company where the content can be tailored to suit the needs of the organization.
You need this course if...
- You have a regulatory / quality role, or research / design / development role, or an internal / external auditor role, or another role having a remit concerning the MDR, and you want to be able to apply the requirements of the MDR.
You will be able to…
- Explain the European CE marking approach for MDRs including its legal and operational basis.
- Describe the structure and scope of the MDR including classification and conformity routes.
- Apply the essential requirements including labelling and develop suitable technical documentation.
- Identify the regulatory significance of risk management and process validation.
- Combine knowledge gained from the course with audit qualifications to conduct compliance audits of your own organization and suppliers.
- Create technical documentation to support the product throughout its life cycle.
- Explain the role and importance of performance evaluation including application of the Common Technical Specification (CTS).
- Interpret the criteria for reporting adverse incidents under the vigilance system.
- Define the manufacturers regulatory responsibilities, including reporting of changes to products and QMS system to the Notified Body.
You will need …
- To possess a basic knowledge of quality management systems for the MDR industry and / or experience of the manufacture, design, marketing or use of medical devices (MDs).
- Ideally to have attended LRQA’s Introduction to the Medical Device Regulation (MDR) training course prior to attending this training course.
Your future development
- Introduction to the IVDR
- IVDR Implementation
- Auditor training
Dates and Locations