Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
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In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices under the new Medical Devices Regulation (MDR 2017/745). For a more detailed look at the European regulatory process for medical devices under the MDR, download the chart above.
The European CE medical device 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.
To obtain CE Marking certification, you must comply with European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR).
Appoint a Person Responsible for regulatory compliance. Determine classification of your device using Annex VIII (Classification Criteria) of the MDR - Class I (self-certified); Class I (sterile, measuging or reusible surgical instrument); Class IIa, Class IIb, or Class III.
For all devices except Class I (self-certified), implement a Quality Management System (QMS) in accordance with the MDR. Most companies apply the EN ISO 13485 standard to achieve compliance. Your QMS must include Clinical Evaluation, Post-Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plans. Make arrangements with suppliers about unannounced Notified Body audits.
For Class I (self-certified), you must implement a QMS though Notified Body intervention is not required.
In accordance with Annex II and III, prepare a CE Technical File or Design Dossier (Class III) providing information about your device and its intended use plus testing reports, Clinical Evaluation Report (CER), risk management file, IFU, labeling and more. Obtain a Unique Device Identifier (UDI) for your device. All devices, even legacy products in use for decades, will require clinical data. Most of these data should refer to the subject device. Clinical studies are generally required for implantable and Class III devices. Existing clinical data may be acceptable. Clinical trials in Europe must be pre-approved by a European Competent Authority.
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 I (self-certified), 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 I (self-certified), 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 I (self-certified), annual NB audits are not required. However, CER, Technical File, and PMS activities must be kept updated.
For all other classes, you will be audited each year by a Notified Body to verify ongoing compliance with the MDR. Failure to pass the audit will invalidate your CE Marking certificate. You must perform Clinical Evaluation, PMS, and PMCF activities to maintain certification.
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.
Chart updated: 05/22/2019