An Overview of the CE Marking Process in the European Union

By The CiteMed TeamPublished On: July 21st, 2019Categories: CE Marking, Miscellaneous

CE Marking Process in the European Union

Introduction

This article will detail the various steps you will need to take for an entire CE Certification cycle for your product. At CiteMed we focus on delivering the CER and accompanying Literature Reviews (the cornerstone of your submission) but believe in having knowledge of the larger submission process.

Classification & Determination Phase

Your compliance requirements are determined by your product classification. Information on how to classify your product can be found online.

While nothing is needed for this phase in terms of physical deliverables, it’s important that you correctly classify your device before proceeding with the CER and Literature Reviews as your classification determines which current regulation applies to your submission (or lack of submission).

Technical and Research Phase

Technical File Preparation

This phase is the meat of your filing, it contains the CER/Literature Review (that CiteMed completes) and also your Technical File.

Clinical Evaluation Report

The Clinical Evaluation Report (CER) is a must for all submissions regardless of product classification. Although please note, that the amount and depth of research required for classifications beyond I is far greater.

The purpose of the CER is to review all current applicable research (or conduct your own in some instances) and make a recommendation to the Notified Body based on your findings.

The Literature Search is always done in conjunction with the CER, and contains a search protocol, the physical research reviewed (Studies + Journal Articles), and a qualified writer’s analysis.

This is by far the most time consuming part of your submission and must be handled by a competent writing team. Many filers run into issues with consistency when doing reports across multiple products, and submitting mistake prone reports quite common (because the documents themselves are so large). At CiteMed, we focus exclusively on this deliverable

Submission Stage

Now that you have your research and Technical file completed, you will enter the final stage of the process which involves making the actual submission.

European Authorized Representative

Before submitting anything, you must appoint an individual as your Authorized Representative to handle all regulatory compliance going forward. The MDR states that this person should be a full-time employee of your organization, but in the cases of smaller companies it can also be an external person or consultant.

Notified Body Submission

At this point in the process, your Authorized Representative will combine your QMS (from stage 1) and your CER/Literature Review (from Stage) and submit it to an EU Notified Body.

If there are no issues from your submission, you will receive a 13485 certificate and a CE marking approval from the Notified Body officially making your product compliant and approved for sale in the EU.

Declaration of Conformity

After receiving your CE marking and compliance certificate from the notified body. Your firm must also write and publish a Declaration of Conformity. While no specific format of this document is required, you can find a list of requirement in Annex IV of the MDR 2017/745 regulation.