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CE Marking 

All medical devices to be marketed in the European Economic Area (EEA) must have CE Mark. The CE Mark confirms that the product meets the requirements of General Safety and Performance of all relevant European Medical Device Regulations. It is a legal requirement to place the device in the market of  European Union.

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To obtain CE Marking certification, manufacturer must comply with European Commission Regulation (EU) No. 2017/745 commonly known as the Medical Device Regulation (MDR).

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Some of the key steps to be followed in obtaining the CE marking are:

Step 1: Classification of medical devices based on, What the medical device is intended for? How does it achieve its intended use? What are the characteristics of the medical device? Identify the key EU Directives and legislations surround this class of medical devices.

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Step 2: Identification of all the relevant European Harmonized Standards and other essential health and safety requirements. It is very important that the medical device shall be in compliant with all the relevant standards. At this point it is  also useful to identify the Notified Bodies  which is  necessary to obtain the CE mark.

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Step 3: Technical file is a necessary requirement for all medical devices. The manufacturer 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. The technical file is proof of compliance and conformity with applicable directives.  

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Step 4: Appointing a European Authorized Representative (EAR) is must for all manufacturers located outside of the EU seeking a CE mark for their medical device because as per EU Medical Device Directive 93/42/EEF Article 14.2: “A manufacturer who does not have a registered address in the European Union may not make his medical devices available in the EU Market unless he first designate an Authorized Representative [or EAR] in the European Union”.

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Step 5: In case of class I products, a manufacturer can 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. If your products fall under the upper class category, you need to seek Notified Body to complete the CE marking process. We can support you in finding the Notified Body and meeting all of your needs.

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Step 6: Once the medical device is certified the manufacturer is finally ready to affix the CE mark. The CE mark must be affixed on both the device and on the relevant package in a clear and visible manner along with the details of the EAR.

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Our services includes:

  • Support to device classification

  • Identification of relevant standards

  • Technical File Preparation

  • QMS Documentation

  • Review of labelling and user manual

  • Verification of compliance with GSPR

  • Preparation of Clinical Evaluation Report

  • Gap Assessment

  • European Authorized Representative (EAR)

  • Review of risk-benefit data

  • Mock Audits & Trainings

  • Software Validation

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