In order to legally commercialize in vitro diagnostic (IVD) devices in the European Union, a CE mark demonstrating compliance with the IVD regulations is required. The CE mark indicates that the legal manufacturer has assessed the device and that it meets the essential requirements under the In vitro Diagnostic Directive 98/79/EC (IVDD) or the general safety and performance requirements under the In Vitro Diagnostic Regulation 2017/746 (IVDR). The legal manufacturer will verify the conformity with all relevant EU requirements and must state this in their EU Declaration of Conformity. Further higher risk devices (list A, B and self-testing under IVDD and Class A sterile, Class B, C and D under IVDR) require an independent assessment by a Notified Body (Certification), which then results in an EC-Certificate issued by the Notified Body confirming the compliance of the manufacturer’s quality management system and technical documentation with the European regulations.
The European CE IVD approval process explained
The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.
Appoint a qualified person responsible for regulatory compliance who is trained in the IVDR.
Determine classification of your device using Annex VIII (Classification Criteria) of the IVDR based on a well-defined intended purpose meeting all IVDR Annex I 20.4.1 c) criteria.
For all devices except Class A (non-sterile), implement a Quality Management System (QMS) in accordance with the IVDR and the harmonized standard EN ISO 13485. Your QMS must include quality process descriptions for the person responsible for regulatory compliance, performance evaluation, post-market surveillance (PMS), EUDAMED registration, economic operator controls, technical documentation and post-market performance follow-up (PMPF). Make written arrangements with critical subcontractors or crucial suppliers about unannounced Notified Body audits. Make written arrangements for economic operators controls (e.g., distributors, importers and EU Authorized Representatives).
In accordance with Annex II and III of the IVDR, prepare technical documentation providing information about your device and its intended use, plus performance testing plans and reports, performance evaluation (scientific validity, analytical performance, clinical performance), risk management, IFU, labeling, PMS, PMPF, EUDAMED registration and more.
Obtain a Unique Device Identifier (UDI) for your device through EUDAMED when required (depending on the Class of the IVD; different timelines apply). Include the UDI in the technical documentation (e.g., IFU, labels, declaration of conformity).
Register the involved entities (economic operators) at EUDAMED. Obtain a Single Registration Number. These will be assigned to all medical device legal manufacturers, Authorized Representatives, system/procedure pack producers and importers involved in placing medical devices and IVDs on the European market.
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 documentation must be audited by a Notified Body, an independent third-party conformity assessment body designated by European national authorities to carry out audits on medical device companies and products within the meaning of applicable European Union legislation.
For all devices except Class A (non-sterile), you will be issued a European Community CE marking (EC) Certificate for your device and an ISO 13485 certificate for your facility following the successful completion of your Notified Body audit. ISO 13485 certification must be renewed every year. EC Certificates are typically valid for a maximum of five years and will be reviewed during your annual Notified Body 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.
For Class A (non-sterile), there is no NB intervention. However, key documents like compliance to state-of-the-art standards, performance evaluation reports, technical documentation, supplier and economic operator controls, vigilance and PMS activities must be kept updated. Market surveillance activities by EU authorities will be through announced or unannounced audits on your site(s), and these audits can include involved outsourced parties and suppliers.
For all other IVD 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. Specifically, you must keep the technical documentation and compliance to state-of-the-art standards up to date and actively include new PMS, and PMPF activities to maintain your certification.
*Note 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) in order 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.