How to Obtain a CE Mark (for a Medical Device)
There’s a common misconception among many medical device manufacturers that obtaining a CE mark 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 obtaining your CE mark is simply a process like any other, much of the undue stress and worry can be taken away.
In this blog entry we will walk through some of the key steps in obtaining a CE marking for medical devices – along with some necessary additional steps for manufacturers located outside of the European Union.
Step 1: Classification
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.
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.
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.
Step 3: Technical Documentation
To obtain a CE mark, 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.
All medical devices of all classes, prior to being awarded a CE marking, 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.
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.
Step 4: Appointing a European Authorized Representative (E.A.R.)
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 EU seeking a CE mark for their medical device must appoint a European Authorised Representative (or E.A.R.).
For more information on the functions and duties of an E.A.R., see our recent blog on the topic.
Step 5: Certification
In 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 who is required to conduct an audit of the technical documentation. Information on CE marking 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 marking process, you can consult Obelis experts and use their assistance in order to find a Notified Body meeting all of your needs.
Step 6: Affixing the CE Marking
Once the medical device is certified the manufacturer is finally ready to affix the CE mark. A medical device’s CE marking must be affixed, on both the device and the relevant packaging, in a clear and visible manner along with the details of the EAR.
Step 7: National Provisions
The final step is complying with the national requirements In order to introduce a medical device into several EU countries (such as France, Greece, Italy, Latvia, Portugal) , the manufacturer has to complete an additional registration with National Competent Authorities.
Obelis is perfectly situated in Europe, with offices in the heart of Brussels, to provide advice and help on the CE marking process and act us your European Authorized Representation. Contact us today to find out how Obelis’ Expert Consultants can be of assistance in the compliance process.Get in touch