This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market. The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.
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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.
Delegates will be able to:
- Develop a strategy for regulatory compliance as stipulated by MDR
- Implement requirements concerning the following steps for Conformity Assessment:
- o Scope and applicability of MDR
- o EU risk classification criteria for medical devices to determine “Risk Class”
- o General Safety and Performance Requirements (GSPRs) as the basis for CE marking, including the use of standards
- o Conformity assessment routes and their application based on risk class
- o Self-certification, CE-certification by Notified bodies, involvement of authorities, scrutiny
- o ‘Declaration of Conformity’ and CE marking
- Fulfil Technical Documentation requirements, e.g. in
- o Putting together ‘Technical Documentation’
- o Necessary control of outsourced activities and processes and roles of external partners (e.g. supplying and commercial)
- o Instantiate the importance and role of clinical data
- o Risk management, process validation and their regulatory significance
- o Drawing up Instruction For Use, label and other information supplied with the device
- o Consistency and validity of information and electronic data management
- Plan post-market activities required by MDR with respect to:
- o Risk Management and related planning
- o Post-Market Surveillance and Post-Market Follow-Up (PMCF)
- o Periodic reports, Vigilance, ad-hoc reporting
- o Regulatory responsibilities of all economic operators including communication with competent authorities, notified bodies, economic operators, customers etc.
- o Recall, Field Safety Corrective Actions (FSCA), Corrective And Preventative Action (CAPA)
- o Regulatory relevance of change control to QMS, design and manufacturing
- o 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
- It's a 2-day course.
- The training and materials will be provided in English
- Lunch and drinks are included
Tid & plats
The training course will take place on several dates.
The price of this training course is € 2150,-
Examen, diplom m.m.
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.
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