In Vitro Diagnostic
Regulation
(IVDR)
CE IVDR certification at Certest
At Certest, since 2024 our products have been certified under the EU Quality System according to Regulation (EU) 2017/746, Annex IX, Chapters I and III.
Specifically, 46 of our products—equivalent to more than 575 catalog references—were the first to receive the EU Quality System certificate in 2024 under Regulation (EU) 2017/746, Annex IX, Chapters I and III.
This achievement reinforced our commitment to quality, safety, and regulatory compliance.
Recently, 18 new products—equivalent to more than 101 catalog references—have received CE IVDR certification.
This brings the total to 64 Certest products with this certification, equivalent to 776 references in our catalog.
64
products
776
references in
our catalogue
What is the IVDR?
Regulation (EU) 2017/746 of 5 April 2017 is the European In Vitro Diagnostics Regulation which updates and replaces Directive 98/79/EC.
The aim of this Regulation is to ensure a high level of health and safety protection for patients and users by regulating in vitro diagnostic devices on the European market. This regulation establishes strict rules for their evaluation, monitoring and traceability in order to ensure that these products are safe, effective and of high quality.
Quality assurance
The CE IVDR certification is added to others previously obtained by Certest in terms of quality, such as ISO 13485, international standard for quality management systems in medical devices.
A firm commitment to quality, reliability and customer satisfaction. Objectives that are and continue to be in its DNA since its creation.
“The CE IVDR certification allows us to significantly improve our processes, giving us the opportunity to continue working day by day to continue being the biotechnology reference we have become in these more than 20 years of effort and work”
Nelson Fernandes, CEO of Certest
Do you want more information?
If you have any questions about this certification remember you can email us.
