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In-Vitro Diagnostics - Europe

Compliance Services


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Background Information 

In-Vitro Diagnostic Regulation (IVDR) 2017/746, replaced In-Vitro Diagnostic Directive (IVDD) 98/79/EC come into full application in May 2022. A new extended  transition  period for certain legacy IVD devices until May 2027 was updated. All In-Vitro Diagnostic (IVD) device must comply with the IVDR in order to obtain a CE marking certification and be sold on the EU market.

In-Vitro Diagnostics Regulation (IVDR)
  • Revised the laws governing  devices to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. The new regulation takes on a life-cycle approach to IVD device regulation instead of the previous directives which are more focused on the pre-approval stage of medical device manufacturing. 

  • For IVD device to be certified, a Quality Management System (QMS) must be implemented. Many companies use the ISO 13485 in their QMS implementation since it is the only QMS standard on the EU harmonized list. 

  • More robust performance evaluation will be conducted to strengthen pre-market approval of higher risk medical devices. 

  • To improve the traceability of IVD device, a unique device identification (UDI) shall also be implemented, and information on devices and studies being made public such as on the European Database for Medical Devices (EUDAMED). 

  • In the new life-cycle approach, there will be requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices.

Definition of In-Vitro Diagnostics Medical Device

‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: :

  • Concerning a physiological or pathological process or state.

  • Concerning congenital physical or mental impairments.

  • Concerning the predisposition to a medical condition or a disease.

  • To determine the safety and compatibility with potential recipients

  • To predict treatment response or reactions.

  • To define or monitoring therapeutic measures.

In-Vitro Diagnostics Device Classification

The IVDR has laid out 7 rules to determine the risk classification of IVD into the following 4 groups based on both patient and public health risk:

  • Class A: Low patient and public health risk (Self-certification)

  • Class A (Sterile): Low patient and public health risk (Subjected to Notified Body audit limited to aspects of manufacture concerned with securing and maintaining sterile condition)    

  • Class B: Moderate patient risk and/or low public health risk

  • Class C: High patient risk and/or moderate health risk

  • Class D: High patient risk and high public health risk

Summary Process of In-Vitro Diagnostic Device to obtain a CE mark in Europe
  1. Determine IVD device classification.

  2. Appoint a "Person Responsible for Regulatory Compliance” (PRRC).

  3. Implement a Quality Management System that includes Performance Evaluation, Risk Management, Post-Market Surveillance (PMS) and assignment of Unique Device Identification (UDI).

  4. Prepare a Technical Documentation. Requirements shall refer to EU IVDR Annex II and III.

  5. System to manage critical supplier.

  6. Conduct a Performance Evaluation.

  7. Appoint an Authorized Representative based in the EU (for foreign manufacturer).

  8. QMS certification audit and Technical Documents review by a Notified Body.

  9. Preparation of Declaration of Conformity (DoC) after certified with IVDR.

  10. Purchase, assign and register device Unique Device Identification (UDI) on EUDAMED.

  11. Affix CE Marking to the medical device.

  12. Actively maintain Post-Market Surveillance activities and preparation for annual audit.

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