Navigating the CE Mark Process for In Vitro Diagnostic (IVD) Devices

To bring in vitro diagnostic (IVD) devices to market in the European Union, obtaining a CE Mark certificate is essential. This certification validates compliance with regulatory standards for IVDs, which are regulated under In Vitro Diagnostic Regulation (IVDR 2017/746).

Here's a step-by-step breakdown of the CE approval process in Europe:

• Step 1:
  To acquire CE Marking certification, you must comply with the  European Commission Regulation (EU) No. 2017/746, known as the In Vitro Device Regulation (IVDR).
• Step 2:
  Appoint a Person Responsible for regulatory compliance and classify your device using Annex VIII (Classification Criteria) of the IVDR* - Class A (Non-sterile); Class A (sterile); Class B, Class C, or Class D.
• Step 3:
  Implement a Quality Management System (QMS) compliant with the IVDR, particularly EN ISO 13485:2016, and prepare for audits by Notified Bodies.
  
  Your QMS must include Performance Evaluation, Post-Market Surveillance (PMS) and Post Market Performance Follow-up (PMPF) plans. Plan in advance with suppliers about unannounced Notified Body audits. For Class A (non-sterile), you must implement a QMS though Notified Body intervention is not required. 
• Step 4:
  In accordance with Annex II and III of the IVDR, compile a CE Technical File or Design Dossier (Class III) containing device information, testing reports, Performance Evaluation Plan, risk management files, IFU, labelling and more.
  
  Obtain a Unique Device Identifier (UDI) for your device.
• Step 5:
  If you do not have a location in Europe, appoint an Authorized Representative (EC REP) located in the EU who is qualified to handle regulatory issues. Place your EC REP name and address on device label. Obtain a Single Registration Number from the regulators.
• Step 6:
  For all devices except Class A (non-sterile), your QMS and Technical File or Design Dossier must be audited by a Notified Body, a third party accredited by European authorities to audit medical device companies and products.
• Step 7:
  For all devices except Class A (non-sterile), you will be issued a European CE Marking Certificate for your device and an ISO 13485:2016 certificate for your facility following successful completion of your Notified Body audit.
• Step 8:
  Issue a Declaration of Conformity in accordance with Annex IV, and affix the CE Marking to your device.
  
  A Declaration of Conformity is a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable European requirements.
• Step 9:
  Register the device and its Unique Device Identifier (UDI) in the EUDAMED database. must be on label and associated with the regulatory documents.
• Step 10:
  Maintain ongoing compliance through annual audits for all classes except Class A (non-sterile).

Changing classifications

Under the IVDR, many self-certified IVDs will require Notified Body involvement, necessitating IVDR certificates for continued market access.

Note: This is a simplified overview of the process. Your Notified Body may choose to audit your submission and request more documents.

We Can Assist with CE Mark Certification:

Our team offers comprehensive support for achieving CE Mark certification. Whether handling the entire process or providing consultancy services, we're here to help. Schedule a consultation today to streamline your certification journey.