Information for manufacturers of COVID-19 rapid tests

The Directive on in vitro diagnostic medical devices (98/79/EC) was established on December 7, 1998 and will be replaced on May 26, 2022 by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017.

In vitro diagnostic medical devices are a group of devices that can assist the patient and physician in making medical decisions. Their growing impact and invaluable diagnostic value have been noticed during the COVID-19 pandemic. IVD tests are becoming more accurate and easier to use, making them an indispensable attribute of the modern medical device market.

According to Directive 98/79/EC, IVD medical devices are divided into four categories: List A, List B, Self-inspection, and also General device. COVID-19 tests can be classified into generic categories or self-testing devices depending on their intended use.

COVID-19 tests, which are intended for use by professionals such as healthcare professionals, are classified as general IVD medical devices and are marketed based on the manufacturer’s declaration. This means that they do not require the involvement of a notified body in the conformity assessment.  

COVID-19 tests that are not intended for professionals, ie non-medical personnel, are classified as self-testing medical devices. This means that they require the involvement of a Notified Body to assess compliance with applicable regulatory requirements.

CeCert, as a notified body, carries out certification processes for medical devices subject to Directive 98/79/EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices (98/79/EC) included in list A and list B specified in Annex II to the above-mentioned of the directive, as well as products for self-testing, including COVID-19 tests

The detailed scope of the authorization granted to CeCert by the Ministry of Health can be found in the decision issued by this authority and on the website of the European Commission, in the NANDO database:
link to the decision
link to NANDO

Code list of in vitro diagnostic medical devices according to the code system used in the NANDO information system: link to IVD codes
 
 

Covid Test

 

 

 

 

 


Examples of nomenclatures for manufacturers of in vitro diagnostic medical devices:

  1. GMDN – Global Medical Device Nomenclature GMDN Agency link
  2. UMDNS – Universal Medical Device Nomenclature System ECRI Institute link
  3. European Diagnostic Manufacturers Association (EDMA) Instrument link
  4. European Diagnostic Manufacturers Association (EDMA) Reagents link

How to get certified?

  1. Ask for a free quote - fill in the Application;
  2. Sign the contract;
  3. Provide us with a complete set of documentation for its evaluation by experts;
  4. As far as it results from the product class, we will arrange a certification audit at a convenient time. SEE - How is the certification process going? (downloadable file);
  5. Decision-making by competent decision-making persons of CeCert permanent staff on the basis of collected audit evidence and documentation evaluation;
  6. Issue of a certificate valid for 5 years;
  7. Join the group of CeCert's satisfied customers.

Why CeCert?


Professionals in every way
Our team consists of experts with many years of experience in the industry. We are product and system auditors with international certificates, thanks to which we provide the possibility of carrying out audits both in the country and abroad. Please contact us to discuss the terms of cooperation.

First of all, the customer
Customer satisfaction is our overriding goal, which is why we are constantly working on the development of our offer. It is equally important for us to carry out the certification processes efficiently and quickly, which is why we declare a priority approach to each inquiry. We invite you to get a free quote for our services.

Selected CeCert customers:

Do you have questions or concerns?

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