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.
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
Combination discount MDR training courses
Attending several medical device courses is associated with special discount.
| 1. Transition or Requirements MDD - MDR |
| 2. Implementing CE Marking MDR |
| Combination training courses 1 + 2 |
In-house training courses
We can deliver this training course to your team in-house. Training in-house allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.
For more information about the in-house training or to request a quote, please contact Training via +31 (0)20 346 07 80 or send an email to training.nl@bsigroup.com.
Who should attend?
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 In Vitro Diagnostics or concentrate on devices with specific requirements.
Prerequisities
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.
Delegates will be able to:
- 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
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 the classroom training
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-346 0780.
