Medical and Regulatory Affairs

Medical Device and IVD Insights: Mastering the 7 Steps of the CE Certification Process

CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), there has been a significant overhaul of the regulatory framework governing the approval, manufacture, and distribution of medical devices and IVDs. Many products that may once have been eligible for self-certification must now undergo conformity assessment and potentially CE certification by an EU notified body.

What is a conformity assessment?

Conformity assessment is the critical process of demonstrating that a medical device or IVD meets all regulatory requirements of the MDR or IVDR, respectively. In the context of CE certification, it is the systematic procedure that manufacturers must follow to affirm that their products conform to the relevant EU legislation.

The conformity assessment process varies depending on the type of product and its risk classification for MDR or IVDR:

  • For medical devices, the intervention of a notified body is required for all Class IIa, IIb, and III devices, as well as some Class I devices. For certain Class IIb and III devices, there is a clinical evaluation consultation procedure that may need to be carried out by an independent expert panel based on the clinical evaluation assessment report of the notified body.
  • For IVDs, the intervention of a notified body is needed for all Class B, C, and D devices, as well as sterile Class A devices. For certain Class D devices, there is a new performance evaluation consultation procedure to be conducted by an independent expert panel and, when an EU reference laboratory has been designated for the device, that laboratory should verify the performance claimed by the manufacturer through testing.

There are three conformity assessment routes available, and the manufacturer may be able to select which option to follow depending on the class and type of medical device or IVD. These pathways are listed in Article 52 of MDR and Article 48 of IVDR:

  1. Annex IX – Conformity assessment based on a quality management system (QMS) and an assessment of technical documentation. This is the route of choice for most manufacturers.
  2. Annex X – Conformity assessment based on type-examination.
  3. Annex XI – Conformity assessment based on product conformity verification.

What is the CE certification process?

Below are 7 key steps in the CE certification process, from application submission to certificate issuance.

  1. Apply to the notified body
    The manufacturer submits an application to the EU notified body. This application should include the information detailed in the appropriate Annex of the relevant regulation, either MDR or IVDR, based on the chosen conformity assessment route.
  2. Receive a proposal from the notified body
    The EU notified body will generate a proposal based on the information submitted in the application.
  3. Review of the application by the notified body
    The EU notified body will review the application and resulting contract for completeness and request any additional information required.
  4. Assessment of the quality management system by the notified body
    The EU notified body will assess the manufacturer’s quality management system (QMS) against the quality system requirements of the relevant regulation for completeness, effective implementation, and compliance with the regulation.
  5. Assessment of the technical documentation by the notified body
    The EU notified body will assess the technical documentation for completeness and identify any gaps. The exact requirements for the technical documentation will be based on both the device classification and the appropriate conformity assessment route.
  6. Final review by the notified body
    The EU notified body will conduct a final review of the activities undertaken and, if satisfied that the requirements have been met, will prepare a certification recommendation.
  7. Receive a certification decision
    The EU notified body will conduct a certification decision and, if the product is approved, will issue the CE certificate.

Key takeaway

EU MDR and IVDR have introduced several changes to the CE certification process, with the goal of increasing device safety and effectiveness, ensuring greater transparency, and enhancing traceability throughout the device lifecycle. With the new classification rules codified in these regulations, more devices are being classified into higher risk categories, thus increasing the number of devices subject to notified body assessment. Understanding both the conformity assessment routes available and the steps involved in CE certification can help manufacturers navigate the process with greater confidence and efficiency and bring safe, effective devices to market across the European single market.

To take a deeper dive into the CE marking approval process, click here.