Implementation of Medical Device Regulation for CE Marking Training Course

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.


Who should atttend?

The course is especially suitable for:

  • RA, QM, and QA professionals who need to implement the MDR
  • Personnel 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 In Vitro Diagnostics or concentrate on devices with specific requirements.

Prequisities

Participants must have a good understanding of the requirements in the MDR, which is conveyed by our 1 day Requirements course or our MDD to MDR transition course.

Participants should also have either experience with, or basic knowledge, of quality management systems for the medical device industry, or good understanding of European Medical Device legislation, or some experience in pre-or post-market activities within the EU. 

What will I learn?

By the end of the course delegates will be able to:

  • Evolve 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

Practical information

  • It's a 3-day course
  • The training will be delivered in the Dutch language (or in English when by all delegates required/approved)
  • The materials will be provided in English
  • Lunch and drinks are included

For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-3460780.

Combination discount

Attending several medical device courses is associated with special discount

No.

Training

Price

 

1

 Transition or Requirements MDR-IVDR

    € 750

 

2

 Implementing CE Marking MDR-IVDR

    € 1.950

 

 

 Total

    € 2.700

 

 

 

 

 

 

 

 Investment

 Discount

 

 Combination training 1 + 2 

€ 2.600

€ 100

For more information about combination of courses or in-house training courses, please contact Mark Leenaers via +31 20 346 07 83 or send an email to mark.leenaers@bsigroup.com


In-company

We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:

  • Refresh your team’s skills and boost their confidence
  • Give your team an overview of your management system(s)
  • Train a group of auditors to the same level, using the same consistent techniques

 For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 80 or send an email to mark.leenaers@bsigroup.com