November 7th, 2023 – Written by Mitchell Gorthy
CE Marking: Overview
The European Union (EU) uses the CE marking as a conformity mark to indicate that a product or device complies with EU health, safety, and environmental protection requirements. It signifies that the manufacturer has taken the necessary steps to ensure their product’s conformity with applicable EU regulations. The marking covers a wide range of product categories and is essential for market access within the EU, a market with over 500 million potential consumers. Though for this case, we will be focusing on the marking in regards to medical devices.
How non-EU devices get CE marking in 6-Steps
Step-one: Identify Directives
While it may sound easy, determining whether your product falls under one or more directives can be difficult. Typically, manufacturers will have to go through each of the 24 directives listed on the EU’s website. However, for the sake of this guide we will focus on medical devices. So, now that we have determined that our hypothetical device’s category, the next step is to assess if our product conforms to the applicable directive(s) and, if not, how we can achieve conformity.
Step-two: Verify Requirements
The EU has designed the New Approach Directives to cover all requirements needed for verifying conformity. For the case of medical devices – Directive 93/42/EEC specifies general requirements that the product has to meet.
Step-three: Contacting a notified body?
It is essential to note that for medical devices classified as Class I, the involvement of a Notified Body is unnecessary unless they possess a measuring function or are marketed in a sterile condition. In contrast, devices in Class IIa, IIb, or III require Notified Body involvement. To identify Notified Bodies designated by the EU, it is recommended to consult the NANDO – The New Approach Notified and Designed Organizations database.
Step-four: Check Conformity
Depending on the class of the medical device, the manufacturer has different options as to how to asses the conformity. Additionally, for each class, the manufacturer has the choice between two or more conformity assessment procedures. Each of the conformity assessment procedures consists of the application of one or more Annexes out of Annexes II – VII of the MDD. In any case, the clinical evaluation must be part of the documents which the manufacturer submits to the Notified Body for assessment and the Notified Body issues a certificate that indicates which Annexes have been verified.
Step-five: Technical Documentation
All CE marking directives impose an obligation for the manufacturer to create and make available technical documentation, or technical file, containing information that demonstrates that the product conforms to the requirements of the directive. Moreover, it is imperative to retain this documentation for a minimum of 5 years from the product’s last manufacturing date, extending to 15 years in the case of implantable devices. Furthermore, maintenance is of paramount importance, particularly when the product undergoes modification or is subject to updated conformity assessment procedures.
Step-six: Declaration and Affixing the CE Marking
Once all previous steps are complete it is time to affix the CE marking on your device and receive your declaration. The declaration of conformity typically consists of a single page that communicates to EU authorities: your company’s identify, the product’s reference, the relevant directives, the employed standards, the location of test results, and the individual within your company responsible for compliance. It is an acknowledgement by the manufacturer that they are responsible for the compliance of its products with applicable derivatives.
How can Enerxen help?
Although this six-step overview may seem somewhat simple to follow, it is often time consuming and costly if done ineffectively. Enerxen has a proven track record of maintaining compliance with the EU, and can make specifics such as identifying potential gaps in your assessment easy.
Contact us today to get started towards the path of regulatory success with a complimentary consultation with one of our seasoned experts. We will work closely with you to tailor a regulatory strategy. Additionally, find a more in-depth overview to our service what we do here.
Related Links
Six Steps to CE Marking – Government of Canada