Online Training: Economic Operators workshop

Online Training

13 June 2022 - 17 June 2022

The Codex4SMEs project provides diagnostics SMEs from North-West Europe with various workshops free of charge, conducted by experts from the network. Med-Di-Dia provides a choice of two different workshops.

Expertise may be provided in small dedicated workshops with 3 SMEs in each. As part of the Codex4SMEs program, Med-Di-Dia offers two optional workshops. An SME can apply for only one of the two workshops. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for the workshop.

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 Legal Manufacturers and other Economic Operators.


Course will include:

  • Background to the IVD Regulation and why the IVD Directive is being replaced
  • Identify Economic Operators, including importers and distributors
  • Recognise increased responsibilities of Economic Operators
  • Outline mandatory requirements of Economic Operators

Economic Operators





25 mins

Introduction to Med-Di-Dia

Explain the background to the IVD Regulation and why the IVD Directive is being replaced

Outline the risk classifications and timelines

Introduce Economic Operators

Part A

45 mins

Define the different Economic Operator roles

Discuss increased responsibilities for each of the different Economic Operators

Legal Manufacturer

EU authorised representative



Person Responsible for Regulatory Compliance (PRRC)

Resources/transition time/impact


10 mins


Part B

45 mins


Identify the requirements of the new IVD Regulation and how this will impact your organization and other operators

Understand the significant changes that are being introduced by the new legislation

Describe conformity assessment routes available under the new Regulation in order to CE mark your products

Explain the importance of technical documentation for compliance with the new Regulation

Exercise or Quiz

for 30 mins

Quiz set up based on info covered already


10 mins


Part C

30 mins

FAQs around Economic Operators

Recap & Finish

15 mins

Summary of key takeaways

1-1s (15 to 30 minutes) can be arranged directly at the end of the Workshop should attendees wish to raise any questions in confidence.  A Confidentiality Agreement can be exchanged ahead of any 1-1 discussion.

About service provider Med-Di-Dia

Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. Med-Di-Dia offers a range of services including:

  • EU Authorised Representative
  • Regulatory Strategy for US, EU and Rest of World
  • Assessments against new EU Medical Device / IVD regulations (2017) to assist with transition to new requirements
  • Device classification & predicate device searches (US)
  • US FDA Regulatory Submissions
  • Clinical evaluations
  • Quality Management Systems
  • Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
  • Technical file compilation

How to apply for services?

  • Check your eligibility:
    • Does your company meets the SME definition of the EU?
    • Did your SME receive more than a total of €200.000 of de Minimis state aid between 2020 and 2022? For more information about de-minimis aid. You can find helpful information via these links  de minimis rule and state aid.
  • Before you apply, read the full Business Growth Programme description
  • Select only one of the two services provided by Med-Di-Dia you want to apply for by June 3rd, 2022.
  • Complete application form
  • Submit your application and your de minimis self-declaration

Note: The online training is limited to three SMEs. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for it.

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