Search courses 👉
Professional Training

Fundamentals of the EU IVD Regulation

PTI, Online
Length
5 weeks
Length
5 weeks
Leave your details so the provider can get in touch

Course description

Fundamentals of the EU IVD Regulation

The in-vitro diagnostic sector has undergone a regulatory transformation, similar to that seen in medical devices. Under the existing Directive, the majority of IVDs are self-declared devices. However, under the In-Vitro Diagnostics Regulation (IVDR) they will require some form of conformity assessment by a Notified Body. The soon-to-be implemented Regulation is drastically different to the current Directive as it imposes new requirements on manufacturers and other economic operators on areas such as conformity, device classification and documentation which impact the entire device lifecycle.

This 5-week course will inform you of the full revised scope of the IVDR and will highlight the key areas of change from the pre-existing Directive. Once completed you will be better placed to carve out a strategy to manage transition, ensuring your organisation and its product(s) remain compliant. To support you in the learning process you will have access to case studies to illustrate this theory in practice.

Do you work at this organisation and want to update this page?

Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.

Suitability - Who should attend?

This course is relevant to those moving into, or new to IVD regulatory affairs within an IVD company, such as:

  • R&D
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Management
  • Project Management
  • Quality Assurance
  • Professionals looking for a complete update on the IVD requirements
  • Anyone looking to obtain or enhance their understanding of the IVD requirements

Outcome / Qualification etc.

  • Gain a comprehensive insight into the latest developments outlined in the new Regulation
  • Understand how to classify your device and distinguish it from others
  • Examine the roles and responsibilities of Competent Authorities, Notified Bodies and Economic Operators
  • Critically analyse the various conformity assessment routes
  • Learn about the key updates to post-market surveillance and vigilance activities
  • Recognise the differences between a technical file and a design dossier and how to compile them 
  • Study the updated labelling and CE marking requirements for your device

Training Course Content

  • Module 1: Introduction to IVDR
  • Module 2: General Safety and Performance Requirements
  • Module 3:  Documentations, Clinical Evidence and Clinical Performance of Devices in the EU
  • Module 4:  Post-Market Surveillance (PMS) and Vigilance Responsibilities
  • Module 5:  Compiling your Technical Documentation

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:

4/5

85% had applied content during the course to their role

Delivery rating:

4/5

Get Inspired! Watch the Video

Request info

Contact form

We are unable to connect you directly to this provider. However, our team will connect you to providers of similar courses if you fill out this form and select "Please recommend similar courses"
Country *

reCAPTCHA logo This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Ads