IVDR - From Fundamentals to Technical Documentation – Get Ready for Certification

SGS Academy in Finland is providing a webinar on: 

IVDR - From Fundamentals to Technical Documentation – Get Ready for Certification

The EU IVDR Regulation has significantly changed the requirements for in vitro diagnostic (IVD) medical devices. IVDR (EU 2017/746) replaces the former IVDD Directive and sets considerably stricter requirements for safety, performance, and documentation.

The transition from IVDD to IVDR has presented significant challenges for many organizations, particularly in the areas of technical documentation, clinical evidence, and risk management. The topic is equally important for manufacturers of new devices, as devices must comply with IVDR requirements before being placed on the market.

In addition, the majority of IVD devices are now subject to assessment by a Notified Body, adding a further layer to the conformity assessment process for IVD devices.
This training provides a clear and practical approach to understanding and implementing IVDR requirements within your organization. The course also explains the role of the Notified Body and its processes in IVDR conformity assessment.

The training is conducted in English. Participants may also submit topic-related questions to the expert in advance.

11 November 2026, at 10-16 (UTC +2 Helsinki), Online via Microsoft Teams

After the training course, participants will:  

• Understand the structure and key requirements of IVDR for Quality Management Systems
• Identify critical gaps within their organization
• Understand the key requirements for the IVDR technical documentation

• IVD manufacturers and subcontractors
• Regulatory Affairs and Quality Assurance professionals
• R&D and product development teams
• Start-ups preparing for market entry

Agenda:  

Part A: IVDR Fundamentals (Morning session)

• Background and objectives of IVDR
• IVDR -compliant Quality Management System 
• Conformity assessment routes and role of Notified Bodies

 

Expert Speakers: 

Mari Levula, Head of Notified Body IVDR NB Manager, SGS Fimko 
Antti Pihlava, IVDR-expert, Lead Auditor, SGS Fimko

Price:

The training fee is €595 per participant. Students are entitled to a 50% discount, and participants from Healthtech Finland member companies receive a €50 discount off the regular price. If you qualify for either discount, please mention it in the "Additional Information" section of the registration form when signing up for the course. VAT will be added in accordance with the applicable rate.

Registration:

Please register at the latest November 2nd, 2026

Terms:

SGS Fimko reserves the right to cancel a training course no later than two weeks before the scheduled date if an insufficient number of participants have registered. SGS Fimko also reserves the right to change the trainer. Participants may cancel their registration free of charge up until the registration deadline. If a participant cancels after the registration deadline, or fails to cancel their registration, no refund will be issued. If you become ill or are otherwise unable to attend the training, please inform us as soon as possible. A registered place may, if necessary, be transferred to another participant in the same company.

Mari Levula
p. 044 7441 308

Training arrangements: 

Anne Paakkunainen
Training Coordinator
p. 043 8249 144