If you are a manufacturer and you want to place your medical device on the EU market, you need to make sure it complies with the specific European Directives set forth by the European Commission. In that case, of importance are the Medical Device Directives (MDD): AIMDD 90/385/EEC; MDD 93/42/EEC; IVDMDD 98/79/EC. To prove that your device complies with the essential requirements of these CE directives, you need to affix a CE mark to it. For that purpose, your product needs to go through the CE marking process. The direction of the latter depends on the class of your medical device and your choice of a conformity assessment route. Specific characteristics of your medical device will determine its class, and respectively how risky it is for the patients. For instance, characteristics such as intended use, invasiveness, and local vs. systemic effects.
According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. The medical devices of Class III hold the highest risk. Today, due to the stricter rules of the new Regulation system, the class of many devices changed. Before they would’ve been placed in class IIa or IIb, but now they will be in class III. If your medical device is in any other class apart from class I, you will have to provide the Notified body with proof that your product fulfils the essential requirements of the respective CE directives. Keep reading to learn more about each class and what steps you will need to pass to CE mark medical devices.
Class I Medical Devices
Medical devices class I have the lowest perceived risk. The manufacturers of such devices can choose one out of three possible CE marking routes. In this regard, they should consider the following: if the medical device is sterile, e.g., a personal protection kit; if the medical device has measuring functions, e.g., stethoscope; and, if it’s not sterile, nor measuring, e.g., corrective glasses. If your product is class I, and it’s not a sterile or measuring device, then all you need to do is to self-certificate it, and formally declare its compliance with the applicable requirements of the MDD via a written statement. If it’s a sterile or a measuring medical device, then you will need a Notified body assessment.
Table 1: CE marking routes of Class I Medical Devices
Class IIa Medical Devices
Medical devices of class IIa could be such as surgical gloves, hearing aids, diagnostic ultrasound machines, etc. They usually constitute low to medium risk. Patients should use them for a short-term period, any less than 30 days. If you are a manufacturer of a class IIa medical device, you will have to back up your declaration of compliance with a Notified body assessment. Only then, you will be allowed to place your product on the market. There are four possible routes to CE mark your product, split into two groups given the product’s type, i.e., if it’s sterile or not.
Table 2. CE marking routes of Class IIa Medical Devices
Class IIb Medical Devices
Here, we can include medical devices such as long-term corrective contact lenses, surgical lasers, defibrillators, and others. They are medium to high-risk devices, and patients may use them for a period longer than 30 days. In case your product is in class IIb, similar to the procedures in class IIa, you will need a Notified body to assess your technical documentation for compliance with the Medical Device Directive. The choice of a specific CE marking route will depend again on the type of your product.
Table 3. CE marking routes of Class IIb Medical Devices
Class III Medical Devices
In that class, all medical devices have the highest risk possible, and permanent monitoring is required during their lifetime. There are specialized institutions responsible for conducting the products’ monitoring. Such devices are, for instance, cardiovascular catheters, aneurysm clips, hip-joint implants, prosthetic heart valves, and others. Here, and also in class II, the conformity assessment of the medical devices may include an audit of the technical documentation and a quality system/product inspection, and to be focused on one or more aspects of the device design and production.
Table 4. CE marking routes of class III Medical Devices
For more information on Medical Device classification and certification, please contact us. We at Clever Compliance, previously CECHECK, can answer all of your questions. Access our compliance store to explore the range of product certification services we offer or have a look at our product compliance management system for enterprises.