Guide for obtaining a CE Mark
A CE mark logo is an essential identification for medical devices of a certain class. The process ranges from identification to declaration, where documentation plays a vital role. Our Experts have cut through the maze of confusion by outlining the following steps for successfully securing a CE mark for your Medical Device.
Step 1: Identify the regulation and standards applicable to your product
It's essential to know if the product even needs a CE mark (medical or non-medical). There are more than 20 product directives and regulations which cover a broad variety of products. A CE mark is necessary if the product falls under any one or many CE mark directives or regulations. Examples of these products can be electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.
Step 2: If a medical device, identify the Essential Requirements (MDD) or General Safety and Performance Requirements (MDR)
Demonstration of Conformity depends on the use and classification of the product. Each Directive or Regulation uses different methods to demonstrate conformity. They will have a requirement checklist which must be complied with. If any aspect is not applicable, a justification must be presented which clarifies why it is not relevant (‘Essential Requirements’).
Usually, requirements of ‘Harmonised European Norms’ (Standard) known as hENs are used as a guide to ensure companies are compliant with applicable requirements.
hENs can be identified by searching the ‘official journal’ on the European Commission’s website.
Step 3: identify an appropriate route/need of a third party
Since the CE Marking process for a Class I medical Device is always via self-declaration, the need for a third party may arise. Depending on the Directive, the attestation system may vary, affecting the need of a third party. Products such as invasive medical devices or fire alarm systems may, to some extent, have a mandatory requirement for some involvement of an authorised third party.
Step 4: Assessment of the product’s conformity
After determining all the requirements, you need evidence to prove that the product meets the essential requirements (Medical Device Directive) or general safety and performance requirements (Medical Device Regulation).
This step usually requires certain assessment and/or testing. It often revolves around ensuring that the requirements of the applicable harmonised standard(s) hENs, identified in step 2, have been addressed.
Step 5: Compilation of the technical documentation
Information covering every aspect associated with conformity, technical documentation, product design, and manufacturing process needs to be compiled. This documentation is often known as the Technical File or Technical Construction File.
Technical description. Drawings, circuit diagrams and photos.
Technical documentation can be on paper or in electronic format and must be held for a period of up to 10 years.
Step 6: Make a declaration and affix the CE mark.
Depending on the need of the Directive or Regulation, whenever the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable CE Marking Directives, a declaration must be completed. Based on the process or nature of the declaration, it can be known as the EU Declaration of Conformity, Declaration of Incorporation for partly completed machinery and Declaration of Performance for construction products.
Read About how to affix the CE Mark.
This process requires extensive efforts and clear communications about the product. Compiling technical files or identifying the correct directives can be tricky!
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