Information for manufacturers of medical devices for in-vitro diagnostics

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.

Compulsory certification of in vitro diagnostic medical devices in accordance with Directive 98/79/EC applies to manufacturers placing their devices on the market in the EU, the European Free Trade Area (EFTA), Switzerland, Turkey and some other countries which are on the way to join the EU structures.
CeCert, as a notified body, as part of its activities carries out certification processes for medical devices subject to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (98/79/EC) classified as list A and list B specified in Annex II to the above-mentioned of the directive as well as self-testing devices.

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

 

 

Covid Test

 

 

 

 

 

Related
products:


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
Satisfaction and 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?

Contact us!