European Union Market
CE Marking
Assisting businesses in obtaining the CE marking for your products.
Medical Device
IVD
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What is CE Marking?
CE Marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Why is CE Marking important?
Assurance
It provides assurance to regulatory authorities and healthcare providers that the device meets the essential safety and performance requirements.
Patient Safety
Obtaining CE Marking helps ensure patient safety and enables manufacturers to access the European market, which can significantly increase their revenue and market share.
Compliance
Failure to comply with the MDR and obtain CE Marking can lead to consequences such as removal of the device from the market, financial penalties, and damage to the manufacturer’s reputation.
Market Access
CE Marking is essential for medical device manufacturers who intend to sell their products within the EEA.
Process Flow for CE Marking
Determine Relevant Directives: Identify the EU directives or regulations applicable to your product, as they outline the essential requirements for CE marking.
Conduct Conformity Assessment: Choose the appropriate conformity assessment procedure based on your product category and directives.
Prepare Technical Documentation: Create thorough technical documentation showcasing how your product meets the applicable directives. This typically includes design specifications, risk assessments, test reports, user manuals, and quality control procedures.
Perform Testing and Certification: Conduct the necessary tests and assessments to ensure your product complies with relevant standards and requirements.
Compile Declaration of Conformity: Develop a Declaration of Conformity (DoC) as an official document affirming your product’s adherence to all applicable requirements. The DoC must accompany your product and include essential information like product details, conformity assessment route, and the responsible party’s identification.
Affix the CE Marking: Once all requirements are met, affix the CE marking visibly, legibly, and indelibly on your product, packaging, or accompanying materials.
Fulfill Post-Market Obligations: Ensure ongoing compliance with post-market obligations such as monitoring product performance, addressing customer complaints, and keeping technical documentation up to date.
Consider Authorized Representative (if applicable): If you are a non-EU manufacturer, you might need to designate an authorized representative within the EU to handle compliance matters and communicate with relevant authorities.
How can we help in CE Marking?
Choose to appoint CliniExperts as your trusted partner for comprehensive compliance solutions.
CliniExperts team will assess the compliance of your technical documentation in order to be sure it fulfils the requirements of the applicable CE Marking Regulations.
We can help you find a Notified Body for mandatory product conformity assessments and assist with accessing global markets for Free Sales Certificates (FSC) on behalf of the manufacturer.
We can assist you as a Marketing Authorization Holder.
We can help you with MDR Compliance.
Regulatory requirements for CE Marking
Timeline
Device testing, pre-clinical studies, clinical evaluation, design documentation, and labelling will take no more than 5-6 months, whereas notified body review will take 6-10 months.
Regulatory Body
The regulatory body responsible for CE marking in the EU is the European Commission. Notified Bodies are appointed by the EU Member States and these only apply to CE Marking.
Fees
If you as a manufacturer carry out the conformity assessment yourself, you won’t have to pay any fees. However, if you opt to use the services of a notified body, or if the EU specifications applicable to your product require the independent assessment by a notified body, then you must pay the notified body for the service they provide. The cost depends on which certification procedure that applies to your product and the complexity of the product etc.
Validity
CE marking does not have a specific validity period. Once a product has obtained CE marking, it is typically considered valid until there are significant changes to the product that could affect its compliance.
Technical Documents Required for CE Marking
Clinical Evaluation of Medical Devices
Clinical evaluation is a continuous process of generating, collecting, analyzing, and evaluating clinical data under assessment in order to demonstrate conformance with general safety and performance requirements as per the manufacturer’s intended use. It begins at the development stage and continues throughout the life cycle of medical devices.
Clinical Performance Evaluation of IVD’s
The clinical performance describes the usability of the specific device in a clinical context. Together with the analytical performance and the scientific validity, it goes into performance evaluation: based on performance data, both the requirements relevant to performance and the assessment of risks and the acceptance of the benefit/risk ratio are demonstrated.
