In order to commercialize in vitro diagnostic (IVD) devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for IVDs, which will soon change under the new In Vitro Diagnostic Regulation (IVDR 2017/746).
The CE Mark Process: Step-by-step approach
The 10 steps below illustrate the CE approval process in Europe.
To obtain CE Marking certification, you must comply with European Commission Regulation (EU) No. 2017/746, commonly known as the In Vitro Device Regulation (IVDR).
Appoint a Person Responsible for regulatory compliance. Determine classification of your device using Annex VIII (Classification Criteria) of the IVDR* – Class A (Non-sterile); Class A (sterile); Class B, Class C, or Class D.
For all devices except Class A (non-sterile), implement a Quality Management System (QMS) in accordance with the IVDR. Most companies apply the EN ISO 13485 standard to achieve compliance. 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.
In accordance with Annex II and III of the IVDR, prepare a CE Technical File or Design Dossier (Class III) providing information about your device and its intended use plus testing reports, Performance Evaluation Plan, risk management file, IFU, labelling and more. Obtain a Unique Device Identifier (UDI) for your device.
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.
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.
For all devices except Class A (non-sterile), you will be issued a European CE Marking Certificate for your device and an ISO 13485 certificate for your facility following successful completion of your Notified Body audit. ISO 13485 certification must be renewed every year. CE Marking certificates are typically valid for a maximum of 5 years but are typically reviewed during your annual surveillance audit.
Prepare a Declaration of Conformity in accordance with Annex IV, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable European requirements. You may now affix the CE Marking.
Register the device and its Unique Device Identifier (UDI) in the EUDAMED database. UDI must be on label and associated with the regulatory documents.
For Class A (non-sterile), annual NB audits are not required. However, your Performance Evaluation Report, Technical File, and PMS activities must be kept updated.
For all other classes, you will be audited each year by a Notified Body to ensure ongoing compliance with the IVDR. Failure to pass the audit will invalidate your CE Marking certificate. You must perform Performance Evaluation, PMS, and PMPF activities to maintain certification.
It is estimated that 80% of the current self-certified IVDs will be up classified to require Notified Body involvement under the IVDR.
IVDs that are up-classified from self-certified to require Notified Body involvement will need a Notified Body-issued IVDR certificate on the date of application (26 May 2022) to continue to market the product.
*This is a simplified overview of the process. Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval.
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