CE Marking a Medical Device
CE marking a medical device and placing it on the market in the EU requires several steps that need to be taken.
In this blog article, we look at the steps and the questions that you need to ask.
Does the Product Meet the Definition of a Medical Device?
The first step is to determine if your product meets the definition of a medical device under the EU Medical Device Directive (MDD) 93/42/EEC definition:
What Is A Medical Device?
‘medical device’ means any instrument, apparatus, appliance, software, material or another article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- the investigation, replacement or modification of the anatomy or a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
What is the Intended Use of the Product?
You need to define the intended use of the product.
Ask yourself –
- what medical condition is the product intended to diagnose or treat?
- what is the mode of action of the product; who is the intended user (layperson / professional), and what patient population will the product treat?
What Is the Risk Classification of the Product?
The next step is to determine what risk classification the product falls in to. Annex IX of the MDD outlines 18 Rules from which you can determine the classification of your product. Examples of factors that influence the classification include the degree of invasiveness; anatomical location and length of time that the product is in contact with the body; whether or not the device is sterile or has a measuring function; whether the device incorporates a medicine.
There are 4 classification categories:
- Class I is the lowest risk category;
- Class IIa is low to medium risk;
- Class IIb is medium to high risk, and
- Class III is the highest risk category.
Also, there are 2 sub-classes for Class I: Class I devices that are sterile and Class I devices that have a measuring function.
Compliance with the Essential Requirements
All classes of medical devices must comply with the applicable Essential Requirements listed in Annex I of the MDD. The Essential Requirements include requirements for safety, performance, design, and construction, as well as labelling and instructions for use requirements.
Conformity Assessment Procedure
Several procedures for demonstrating conformity with the directive are outlined in the Annexes of the MDD. The manufacturer can choose from these procedures, appropriate to the classification of the product. Notified Body involvement is required for CE certification of products other than Class I non-sterile/non-measuring function. Depending on the conformity assessment procedure and classification of the product, this may include review/approval of the technical file and audit of the product design and manufacture.
A technical file must be compiled that describes the design and manufacture of the product, and the solutions the manufacturer has taken to demonstrate conformity with the Essential Requirements. Also, a clinical evaluation report must be prepared to assess the clinical evidence that supports the safety and effectiveness of the device. The manufacturer must have the technical documentation available for inspection by regulatory authorities.
A system for post-market surveillance must be implemented to ensure that incidents are assessed and reported to the national competent authority and to review information gained in the post-market phase.
Declaration of Conformity and Affixing the CE Mark
Once all other steps have been completed, the manufacturer signs a declaration of conformity to the MDD. The product has the CE Mark affixed to it and can be sold throughout the EU.
We Can Help
Our team of medical device experts can assist you in CE marking a medical device. Call our team today on 00353 52 61 76706 or complete the form below and we will get back to you.