The first stages of the CE marking Certification process is to determining which class or category is applicable for the certification of Medical Device Products. Our experts classify your medical device based on the information you send us i.e. pictures, intended use, general information, user manual and the properties of the product concerned.
Which classification does a Medical Device product (MD) fall into?
A medical device product may be classified as
- Class I (including Is & Im), Class Is is a class I device which is sterile. And a Class Im device is a Medical Device with a measuring function.
- Class IIa,
- Class IIb and
- Class III, covering the highest risk products.
The higher the classification the greater the level of assessment and criteria required. All Class Is, Im, IIa, IIb and III medical devices require the intervention of third party: the so-called Notified Body. Class I non-sterile Medical Device without a measuring function does NOT require the involvement of a Notified Body. A declaration of conformity should be compiled and the manufacturer should register with the Competent Authority. Finally the CE Mark can be affixed and you can retain the declaration of conformity & supporting evidence of the Competent Authority.
The classification rules are set out in Annex IX of the Medical Device directive. Annex IX explains all definitions of the terminology used in the classification rules. Classification of a medical device will depend up on a series of factors, including:
- how long the device is intended to be in continuous use
- whether or not the device is invasive or surgically invasive,
- whether the device is implantable or active
- whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?
The IVD Directive (98/79/EC) groups In Vitro Diagnostic products into four categories. These categories are, in order of increasing perceived risk:
- Other/General Device:
all devices except Annex II and self-testing devices;
Annex II is sub-devided into two lists, List A and List B. All Annex II IVD’s require the involvement of a Notified Body before the product can be placed on the market
- Device for Self-Testing (not listed in Annex II):
a device intended by the manufacturer to be able to be used by a person in a home environment, excluding self-test devices covered in Annex II;
- Device of List B, Annex II:
This category includes reagents and products for rubella, toxoplasmosis and phenylketonuria as well as devices for self-testing for blood sugar;
- Device of List A, Annex II
The last category includes reagents and products for human immunodeficiency virus I and II, hepatitis B, C and D.
Our experts are highly experienced in the classification of your medical product. Whether it is an Medical device or In Vitro Diagnostic Medical Device. For more information or if you want to classify your Medical Device product, please contact us, using one of the following methods.
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