There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC), and will impose new requirements on manufacturers and other Economic Operators.
This long awaited text brings a number of significant changes to the regulatory requirements for IVD manufacturers, addressing the challenges posed by the IVD Directive. The changes include a new rule-based classification system, increased scrutiny of technical documentation, and improved traceability of devices through the supply chain.
Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR).
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
Attending several medical device courses is associated with special combination discount.
| Price | Discount | |
| 1. Transition or Requirements IVD - IVDR | € 845 | |
| 2. Implementing CE Marking IVDR | € 2.150 | |
| Total | € 2.995 | |
| Combination training 1 + 2 | € 2.895 | € 100 |
In-house training courses
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on 0031 (0)20 346 0780 or send an email to training.se@bsigroup.com.
Who should attend?
- Medical device manufacturers, especially if your role is in:
• Regulatory Affairs
• Design and Development
• Clinical Affairs Specialists
• Quality Management
• Quality Assurance
- Authorized Representatives
- Economic Operators, including importers and distributors
- Consultants
Delegates will be able to know the:
- Requirements and impacts of new IVDR
- Key aspects of the transition - from Directive to Regulation
- Changes to responsibilities of Economic Operators
- Significant changes introduce by the new IVDR
- Revised scope, risk-based classification, and conformity assessment
- Revised clinical expectations
- Managing the transition
- New expectations for post-market activities
- Technical documentation for compliance
Practical information
- It's a 1-day course.
- The training and materials will be provided in English
- Lunch and drinks are included
- On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.
