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.
Need Help?
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.