🇨🇿 Intended purpose and classification of IVDs in practice

The event is held in Czech language only!

Determining the intended purpose, qualification, and subsequent classification under the IVDR is not just the initial set of formal steps in the conformity assessment process. Proper execution of these activities represents a key issue for shaping the overall regulatory strategy with far-reaching implications. Insufficient or incorrect definition of the intended purpose can lead not only to regulatory shortcomings, but also to a significant prolongation of the certification process and thus to unnecessary and unpleasant financial expenses.

In our webinar, we will create a practical guide that will walk you through all the qualification and classification procedures step by step. We will look at how to structure the intended purpose correctly and which requirements it must meet based on the IVDR. We will also focus on controversial and borderline cases of qualification and classification. We will supplement the explanation with a large number of practical examples and point out the most common mistakes so that the conclusions can be immediately applied in your own practice and regulatory strategy.

Who the webinar is for:

• Regulatory specialists of IVD manufacturers

• Employees from the quality and PRRC departments within the IVD manufacturing sector

• Regulatory specialists of IVD importers and distributors

• Anyone who works in the field of medical device and IVD regulation and wants to broaden their horizons on this issue

  
  

Speakers:

• Ing. Jakub Musil

• Ing. Tereza Sulejová

Content:

• Definition and structure of the intended purpose based on the requirements of Annex I of the IVDR

• Impact of the intended purpose on aspects of the conformity assessment process

• Basic principles of qualification according to the IVDR

• Definition of the scope of in vitro diagnostic medical devices, borderline and potentially controversial cases of qualification

• Basic principles and classification process according to IVDR, implementation and classification rules according to Annex VIII of IVDR

• Practical classification cases and presentation of controversial and borderline cases

Further information:

• Participants will have the opportunity to ask questions during the webinar

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT 

• 100 % cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar organized by:

• Porta Medica s.r.o.

  IČ: 03301931, DIČ: CZ03301931

  Registered office at Opletalova 1525/39, 110 00, Prague 1 - Nové Město