Getting your medical device CE marked is mandatory to launch and legally sell it in the European Economic Area (EEA). However, many medical device manufacturers find the process rigorous and complex. This is mainly because the regulatory directives and requirements for medical devices, set by the EEA, are stringent—rightly so—and can vary depending on its type.
Preparation and creating a strategy in the early phases of the development process is, therefore, essential for medical device manufacturers to efficiently deal with the inherent robustness of the erected protocol.
In this article, we briefly walk through the steps required to successfully get a medical device CE affixed, and as such, every medical device manufacturer’s CE marking strategy should be structured around these steps.
Step #1: Establish the Regulatory Context
The European General Medical Devices Directive is divided into three subsets of key directives, with each of those subsets governing the requirements for a particular type of medical device.
- EU Directive 93/42/EC:This directive governs all types of medical devices that are to be specifically used for diagnosis, prevention, monitoring and treatment of a medical disease or an injury. It also includes devices that are intended to be used for the control of conception or for the investigation of anatomy or a physiological process. Some examples are patient monitor, ventilator and X-ray machine.
- EU Directive 98/79/EC:The 98/79/EC directive governs all types of medical devices that are used for in-vitro diagnosis. These devices are called in vitro diagnostic medical devices or IVD devices. Some examples of IVD devices are tissue processors, absorbance microplate reader and immunoassay analyzer.
- EU Directive 90/385/EC:This directive contains regulatory instructions and requirements for medical devices that are used as active implants. Active implantable devices are those medical devices that are surgically or medically introduced into the human body serving as an effective intervention against a medical condition. Some examples include implantable pacemaker, cochlear implants, implantable neuro stimulator systems etc.
The third category of medical devices, that is the active implants, fall outside the scope of this article and as such won’t be dealt further with. However, it’s important to establish if your medical device falls into the EU Directive 90/385/EC or not.
Step #2: Determining the Device-Specific Class
Once you have established the regulatory context, the next step is to determine the device specific class of your medical device. Medical devices, as governed by the EU directives 93/42/EC and 98/79/EC, are further classified into device specific categories.
- IVD devices are sub divided into General IVD, Self-Testing IVD, List B IVD and List A IVD.
- Other medical devices category is sub-categorized into Class I, Class IIa, Class IIb and Class III.
Each of these subclasses have their own conformity assessment procedures and regulatory requirements that need to be followed.
Step #3: Verify with the Harmonized Standards
You have identified the regulatory context of your medical device and you have also determined its device-specific class. Now you need to work on verifying the standards that have been defined in the EU directive for your medical device.
Step #4: Document the Verification
After verifying that your medical device complies with the established standards and requirements, you then need to document the verification. This is done by preparing a technical dossier of your medical device which would include design and manufacturing details and the intended operation of your product.
Step #5: Embark on the Conformity Assessment Route
As previously stated, every device specific class has its own conformity assessment route. Most would require the involvement of a notified body, while some won’t—those that fall in the Class I sub category and are non-sterile.
Where required, coordinate with the notified body, submit your technical dossier and wait for Notified Body to issue the certification of conformation. Where there is no involvement of a Notified Body, the medical device manufacturer must carry out a self-audit and self-declare the device’s conformity with the provisioned requirements.
Step #6: Declaration of Conformity
On the issuance of the certificate from the Notified Body, the medical device manufacturer must then generate a Declaration of Conformity, followed by affixing the CE mark on the product. For those devices that are self-audited and self-conformed, the validation testing and audit report should be submitted to European databank for medical devices (Eudamed) and the device should then be registered at Eudamed. Once registered, it can be CE-marked.
By keeping these steps in consideration, a comprehensive CE marking strategy can be structured and the approval process can thus be simplified.
G&M Compliance can help. The company resources a team of experienced and knowledgeable professionals that specialize in handling CE marking process for medical devices and industrial equipment. The company can help medical device manufacturers in determining the class of their medical device, and working in support from the first step to the very last step, can make the whole process convenient and simple for them. For more details, call at 714 628-1020.