Requirements for a COVID-19 Test Kit

A short half-day course for those intending to place COVID-19 test kits on the market.

This course is designed to provide participants with the knowledge required to place COVID-19 test kits on the market based on the requirements stipulated in the IVD Directive (98/79/EC) and guidance issued by WHO and the European Centre for Disease Prevention and Control (ECDC).

The course will cover the need for performance evaluation, technical file contents and meeting the essential requirements. 

Objective

Upon completion of this course, attendees will have gained an understanding of:

  • The regulatory requirements for placing a COVID-19 test on the market in the EU 
  • The requirements for different types of tests with focus on:
    • Conducting performance evaluation 
    • Technical file contents 
    • Meeting the essential requirements

Audience

This course is suitable for personnel from small and medium enterprises and includes: 

  • Regulatory affairs managers/directors 
  • Technical managers 
  • Development scientists


All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Healthcare; or Contact us if you are interested or want to know more on in-house courses.

This course is designed to provide participants with the knowledge required to place COVID-19 test kits on the market based on the requirements stipulated in the IVD Directive (98/79/EC) and guidance issued by WHO and the European Centre for Disease Prevention and Control (ECDC).

The course will cover the need for performance evaluation, technical file contents and meeting the essential requirements. 

Objective

Upon completion of this course, attendees will have gained an understanding of:

  • The regulatory requirements for placing a COVID-19 test on the market in the EU 
  • The requirements for different types of tests with focus on:
    • Conducting performance evaluation 
    • Technical file contents 
    • Meeting the essential requirements

Audience

This course is suitable for personnel from small and medium enterprises and includes: 

  • Regulatory affairs managers/directors 
  • Technical managers 
  • Development scientists


All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Healthcare; or Contact us if you are interested or want to know more on in-house courses.