The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.
The Regulation will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be affected, as will manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, contact lenses to change eye colour without correcting vision, etc.).
The MDR focusses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, post-market-surveillance (PMS), transparency and traceability. The requirements will also affect (supplier) audits and governmental control, introduce new partners to interact with, and increase communication needs and obligations (e.g. contracts, reporting, documentation, and publication of information).
This course aims to offer guidance on implementation of the requirements stipulated in the MDR. It focusses on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your business and your documentation. Moreover, you should gain confidence and expertise to evaluate and implement more specific requirements on your own.
How will I benefit?
This course will help you:
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD.
The course is especially suitable for:
- RA, QM, and QA professionals who need to implement the MDR
- Anyone concerned with certification or active in projects for CE-marking
- Staff working for organizations that partner with Medical Device manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee
Please note: This course will not cover implementation for the In Vitro Diagnostics or concentrate on devices with specific requirements.
- Develop a strategy for regulatory compliance as stipulated by MDR
- Implement requirements concerning the following steps for Conformity Assessment:
- Scope and applicability of MDR
- EU risk classification criteria for medical devices to determine “Risk Class”
- General Safety and Performance Requirements (GSPRs) as the basis for CE marking, including the use of standards
- Conformity assessment routes and their application based on risk class
- Self-certification, CE-certification by Notified bodies, involvement of authorities, scrutiny
- ‘Declaration of Conformity’ and CE marking
- Fulfil Technical Documentation requirements, e.g. in
- Putting together ‘Technical Documentation’
- Necessary control of outsourced activities and processes and roles of external partners (e.g. supplying and commercial)
- Instantiate the importance and role of clinical data
- Risk management, process validation and their regulatory significance
- Drawing up Instruction For Use, label and other information supplied with the device
- Consistency and validity of information and electronic data management
- Plan post-market activities required by MDR with respect to:
- Risk Management and related planning
- Post-Market Surveillance and Post-Market Follow-Up (PMCF)
- Periodic reports, Vigilance, ad-hoc reporting
- Regulatory responsibilities of all economic operators including communication with competent authorities, notified bodies, economic operators, customers etc.
- Recall, Field Safety Corrective Actions (FSCA), Corrective And Preventative Action (CAPA)
- Regulatory relevance of change control to QMS, design and manufacturing
- Extent of readiness for audits/reviews/assessment
- Put into effect gained knowledge concerning implementation of MDR requirements into your organization, e.g. in projects for CE-marking
- Training course notes
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate