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.

Management Systems Training

APQP4Wind Training

APQP4Wind is the common frame of reference to be used in the industry to strengthen the cooperation between manufacturers and suppliers

Environment and energy training

Public concern on environment and energy issues, stricter environmental legislation and increased media attention put more demands on businesses today

Food safety training

The food and beverage industry is moving to satisfy demands from international consumers and to open new market opportunities

Health and safety training

Your company is expected to care for its employees by managing safety and health in a professional way

Healthcare training

Every patient and service user across the globe should get the best care possible

Medical devices training

Production of medical devices is a strictly regulated business. In almost all countries, and for most medical products, there are requirements and standards to which manufacturers need to show compliance

Quality & performance training

An effective quality management system in place can improve your company’s quality processes and overall performance and success

Social responsibility training

Ensuring your commitment to safeguard human rights and operate in an ethical, responsible manner is essential to instill ethical practices and promote a culture of corporate sustainability