In Vitro Diagnostic
Regulation
(IVDR)
CE IVDR certification at Certest
In Certest 46 of our products, equivalent to more than 575 references in catalogue, have since 2024 the EU Quality System certificate under Regulation (EU) 2017/746, annex IX, chapters I and III.
An achievement that reinforces our commitment to quality, safety and regulatory compliance.
46
products
575
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
We have been accredited by the Notified Body TÜV Rheinland in accordance with the requirements of the IVDR Regulation, which include updates to technical documentation, improvements to quality management systems and the implementation of new after market surveillance measures.
Do you want more information?
If you have any questions about this certification remember you can email your Export Area Manager.
