2024-12-21 2024-12-21 , online online, 1,390 € plus tax Beni Hirt https://forum-institut.com/seminar/25042181-transition-process-ivdd-to-ivdr/referenten/25/25_04/25042181-seminar-online-transition-process-ivdd-to-ivdr_hirt-beni.jpg Transition process IVDD to IVDR

Are you working in Switzerland or for a Swiss company and need a concise overview of the new IVDR regulation and their practical implementation in Swiss law? Then you should attend this seminar!

Topics
  • In-Vitro Diagnostic Regulation and In-Vitro Diagnostic Directive - the differences
  • IvDO: translation of the new requirements into Swiss law
  • Conformity assessment and CE marking
  • Product design, technical documentation and performance evaluation of IVDs
  • Market access and registration in Switzerland - comparison with EU regulations
  • Post-Market Surveillance and vigilance


Who should attend
This seminar aims at individuals in in-vitro diagnostic and medical device companies who:

  • need a compact overview of the new IVDR framework and the implementation of European regulations into Swiss law.
  • want to acquire detailed knowledge about the regulatory changes in the entire development cycle of in-vitro diagnostics.
Aims and objectives
This seminar informs employees in-vitro diagnostic and medical device companies about the current IVDR regulation and their practical implementation in Switzerland.

After the seminar, participants will understand the changes brought by the transition from IVDD to IVDR and how the new IVDR requirements are implemented into Swiss law (IvDO) as well as how they are applied in practice.

The entire lifecycle of IVDs will be covered in this seminar: from conformity assessment and CE marking, through the necessary documentation and product design requirements, performance evaluation, and registration in Switzerland, to the Post-Market Surveillance of IVDs.

With this knowledge, you will be able to develop your IVDs in accordance with the current requirements, successfully plan the market access to Switzerland, and conduct safety monitoring.
Your benefit

A concise overview of the new IVDR requirements with a focus on the implementation of European changes into Swiss legislation.

Transition process IVDD to IVDR

Transition process IVDD to IVDR

The practical implementation for In-Vitro Diagnostic Medical Devices in Switzerland

Benefits
  • IVD in Switzerland - practical implementation
  • The complete development cycle at a glance
  • Highly experienced trainers
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25042181

Book now

JETZT Buchen
Speakers

Beni Hirt

Decomplix AG, Bern

CEO
More information please click here.

Heike Idink

Decomplix AG, Bern

Senior Regulatory & Quality Consultant
More information please click here.

Helena Lacalle

Decomplix AG, Bern

Regulatory Affairs Director
More information please click here.

Everything at a glance

Appointment

03/04/2025

03/04/2025

Period

09:00 - 17:00 CET
You may join the session 30 minutes before

09:00 - 17:00 CET
You may join the session 30 minutes before
Venue

online

online

Downloads
Fee

Event - 1,390 € plus tax
The fee includes high-quality course material and a participation certificate for download, access to the Learning Space as well as technical support including a test meeting.

Event - 1,390 € plus tax
The fee includes high-quality course material and a participation certificate for download, access to the Learning Space as well as technical support including a test meeting.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

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Ihre Kontaktperson

Elsa Eckert
Stellv. Bereichsleiterin Healthcare

+49 6221 500-650
e.eckert@forum-institut.de

Details

Are you working in Switzerland or for a Swiss company and need a concise overview of the new IVDR regulation and their practical implementation in Swiss law? Then you should attend this seminar!

Topics

  • In-Vitro Diagnostic Regulation and In-Vitro Diagnostic Directive - the differences
  • IvDO: translation of the new requirements into Swiss law
  • Conformity assessment and CE marking
  • Product design, technical documentation and performance evaluation of IVDs
  • Market access and registration in Switzerland - comparison with EU regulations
  • Post-Market Surveillance and vigilance


Who should attend
This seminar aims at individuals in in-vitro diagnostic and medical device companies who:

  • need a compact overview of the new IVDR framework and the implementation of European regulations into Swiss law.
  • want to acquire detailed knowledge about the regulatory changes in the entire development cycle of in-vitro diagnostics.

Aims and objectives

This seminar informs employees in-vitro diagnostic and medical device companies about the current IVDR regulation and their practical implementation in Switzerland.

After the seminar, participants will understand the changes brought by the transition from IVDD to IVDR and how the new IVDR requirements are implemented into Swiss law (IvDO) as well as how they are applied in practice.

The entire lifecycle of IVDs will be covered in this seminar: from conformity assessment and CE marking, through the necessary documentation and product design requirements, performance evaluation, and registration in Switzerland, to the Post-Market Surveillance of IVDs.

With this knowledge, you will be able to develop your IVDs in accordance with the current requirements, successfully plan the market access to Switzerland, and conduct safety monitoring.

Your benefit

A concise overview of the new IVDR requirements with a focus on the implementation of European changes into Swiss legislation.

Detailed programme

09:00 - 17:00 CET
You may join the session 30 minutes before

09:00 Welcome


09:15

Heike Idink

Introduction to IVDR and comparison to IVDD
  • Overview of the In-Vitro Diagnostic Regulation (IVDR)
  • Differences between IVDR and In-Vitro Diagnostic Directive (IVDD)
  • Translation of the new requirements into Swiss law - IvDO (Ordinance onIn-Vitro Diagnostic Medical Devices)
  • In-house diagnostics: Requirements and implementation according to Article 9 IvDO and Article 5(5) IVDR
  • "Legacy" IVDs according to EU regulation and IVDR transition periods

10:15

Heike Idink

Conformity assessment and CE marking
  • Intended purpose of the IVD
  • Classification rules, additional requirements for Classes C and D
  • Specific requirements for certain product categories (CDx, NPT, self-tests, kits)
  • Steps for conformity assessment
  • Responsibilities of Notified Bodies
  • The CE Marking

11:15 Coffee break


11:30

N.N.

Product design and technical documentation
  • Product design requirements
  • Intended purpose of IVDs
  • Technical documentation
  • General Safety and Performance Requirements (GSPR)

12:30 Lunch break


13:30

N.N.

Performance evaluation of IVDs
  • Performance evaluation requirements
  • Analytical and clinical performance parameters, scientific validity
  • Conducting and documenting performance studies
  • Performance Evaluation Report (PER)

14:30

Beni Hirt

Market access and registration in Switzerland - comparison with EU regulations
  • Unilateral recognition of EU certificates of conformity (MRA)
  • Overview and registration of economic operators
  • Requirements for placing non-Swiss IVDs on the market
  • "Swiss authorized representatives" (CH-REP) and their responsibilities
  • Comparison of Eudamed and Swissdamed

15:30 Coffee break


15:45

Helena Lacalle

Post-Market Surveillance and vigilance
  • Post-Market Surveillance (PMS) requirements
  • Incident reporting, field safety reports, Field Safety Corrective Actions (FSCA), trend reports
  • Implementing an effective PMS system in practice

16:45

Final discussion and Q&A

17:00 End of seminar


Additonal Informatio

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

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List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
Abbreviations, Glossary
In-house seminars

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We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality