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IVDR/MDR Public Declaration

Unilabs is among the leading providers of laboratory testing services in Europe, providing diagnostic testing across multiple medical fields. Regulatory compliance at Unilabs is at the forefront of our activities to ensure safety, quality, and accuracy of diagnostic tests.

 

Regulatory

Ensuring regulatory compliance at Unilabs involves adhering to both European Union (EU) regulations and specific national regulations in the regions where Unilabs operates. Some fundamental elements of regulatory compliance at Unilabs include:

  • In-vitro Medical Device Regulation (EU) 2017/746 (IVDR), as set out in the Public Declaration form.

  • Medical Device Regulation 2017/745 (MDR), as set out in the Public Declaration form.

 

Unilabs in-house tests Public Declaration:

Our laboratories have signed the Public Declaration for our in-house tests, confirming adherence to Annex I as per Article 5(5) of Regulation (EU) 2017/746 (IVDR) and/or Regulation (EU) 2017/745 (MDR). 

For more information about our Public Declaration, please visit the following pages:

  • Czech Republic - State Institute for Drug Control (sukl) [Link 1] [Link 2]
  • Denmark - Danish Medicines Agency (dkma) [Link]
  • Netherlands - Healthcare and Youth Care Inspectorate, Ministry of Health, Welfare & Sport [Link]
  • Portugal - National Authority of Medicines and Health Products (Infarmed) [Link 1] [Link 2]
  • Slovakia - State Institute for Drug Control (sukl) [Link]
  • Spain - Spanish Agency for Medicines and Health Products (AEMPS) [Link]
  • Sweden - Swedish Medical Products Agency (Läkemedelsverket) [Link]
  • Switzerland – Swissmedic [Link 1] [Link 2] [Link 3] [Link 4] [Link 5]

 

Consider that certain countries may adhere to their national law, establishing what is needed to be defined nationally, aligning with both IVDR and MDR. For instance, Switzerland adheres to the “SR 812.219 Ordinance of 26 May 2022 on In Vitro Diagnostic Medical Devices (IvDO)” and “SR 812-213 Ordinance of 1 July 2020 on Medical Devices (MedDO)”.

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