7 Steps - How to Get a CE Marking Certification for Medical Devices?

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7 Steps - How To Get A
CE Marking Certification for Medical Device?
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There’s a common misconception among many medical device
manufacturers that Getting a CE Certification is too hard, too costly,
and too complicated. We’re glad to be able to say that this isn’t
true. With some knowledgeable guidance and the understanding
that Getting your CE Certificate is simply a process like any other,
much of the undue stress and worry can be taken away.

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In this Video we will walk through some of the key steps in
obtaining a CE marking Certification for medical devices – along
with some necessary additional steps for manufacturers located
outside of the European Union.

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Step 1: Classification
How To Get CE Marking Certification for Medical Device?
The first step for any manufacturer is to carefully examine their
medical device. What does the medical device intend to do, and
how does it achieve this? Defining the characteristics of the
medical device is a crucial and valuable step. More information on
medical device classification and the ’18 Rules of Classification’ can
be found here.

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Step 1: Classification
A key part of this step is identifying EU Directives and legislations,
the implications they may have for the manufacturer’s medical
device, and ensuring all regulations therein are adhered to. It is
important to note that the onus for this step is solely on the
manufacturer.

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Step 2: Identification
After the medical device has been classified and the surrounding directives have been
clearly underlined, the next step is to identify all relevant European Harmonized
Standards and other essential health and safety requirements. This step is
paramount in ensuring the medical device is compliant with all standards mentioned
above – comprehensive literature on medical device compliance can be found here.
At this point also it is useful to identify if Notified Bodies are necessary to obtain the
CE mark Certification.

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Step 3: Technical Documentation
To Get a CE Marking Certification, the manufacturer then must
complete and compile the necessary technical documentations.
These can include, but aren’t always limited to, medical device
tests, assessments, product inspections and relevant audits. After
this the manufacturer must issue a Declaration of Conformity.

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All medical devices of all classes, prior to being awarded a CE Mark
Certification, require a Technical File. The technical file is proof of
compliance and conformity with applicable directives. A copy of
the technical file must be kept inside the European Union at all
times, available upon request to any EU Competent Authorities.

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If you need any assistance regarding the creation or review of the
Technical File, Obelis Experts will gladly help you as part of
Technical File Services revising the documentation you possess.

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Step 4: Appointing a European Authorized Representative.
According to EU Medical Device Directive 93/42/EEF Article 14.2: “A
manufacturer that does not have a registered address in the European Union may
not make his medical devices available on the EU Market unless he first designated
an Authorized Representative or EAR in the European Union.” As a result of this,
ALL manufacturers located outside of the European Union seeking a CE mark for
their medical device must appoint a European Authorized Representative.
For more information on the functions and duties of an E.A.R., see our recent blog
on the topic.

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Step 5: Certification
In the case of class I products, a manufacturer will then be able to self-certify
the medical device. For upper-class products, the manufacturer needs to work
with a notified body that is required to conduct an audit of the technical
documentation. Information on CE marking Certification and notified body
services can be found here. If your products fall under the upper-class category
and you need to seek Notified Body to complete the CE Certification process,
you can consult CEMarkingExperts and use their assistance in order to find a
Notified Body meeting all of your needs.

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Step 6: Affixing the CE Marking
Once the medical equipment is certified the manufacturer is finally
ready to affix the CE mark. A medical device’s CE marking
Certification must be affixed, on both the device and the relevant
packaging, in a clear and visible manner along with the details of the
EAR.

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Step 7: National Provisions
The final step is complying with the national requirements In
order to introduce a medical device into several European Union
countries such as France, Greece, Italy, Latvia, Portugal, the
manufacturer has to complete an additional registration with
National Competent Authorities.

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Step 7: National Provisions
We are perfectly situated in Europe, to provide advice and help on
the CE marking Certification process and act as your European
Authorized Representation. Contact us today to find out how Our’
Expert Consultants can be of assistance in the compliance process.

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7 Steps - How to Get a CE Marking Certification for Medical Devices?

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