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CE Certification Service
Medical device and In Vitro Diagnostic manufacturers who want to sell their products in Europe must follow new MDR and IVDR standard requirements. The take of notified body application and preparing a technical documentation file is a huge task and a manpower intensive activity. It’s so highly recommended to use experienced CE certification service provider.
A professional CE Certification Service provider helps manufacturers understand European regulations, prepare the required documentation, and complete the TDF and coordinate with notified body and complete EUDAMED registration efficiently.
For medical devices CE applicants must comply with EU MDR 2017/745, while IVD devices applicants must meet the requirements of IVDR 2017/746. These regulations require strong technical documentation, safety evidence, and continuous regulatory compliance. Because of the complexity of MDR-IVDR regulations, many CE appliance and startup manufactures prefer to work with experienced CE Consultants who provide specialized CE Certification Services.
I3CGLOBAL provides high caliber CE Certification Services for medical devices and In Vitro Diagnostic devices producers and CE applicants. Our team of professionals has extensive experience in regulatory documentation, clinical and performance evaluation studies, and Notified Body coordination.
CE Certification Service for Medical Devices
Under new MDR 2017/745, medical devices CE applicants ( New or Legacy Device manufactures) must strictly meet standard guidelines requirements related to safety, clinical performance, and risk management. A professional CE Certification Service provider can only help support manufacturers in the following areas:
⇒ Medical device classification and selection of Certification route
⇒ Preparation of MDR Technical Documentation File
⇒ Clinical Evaluation Report documentation with strong derivation of conclusion
⇒ Risk Management File documentation and risk mitigation as per ISO 14971
⇒ Biological Evaluation plan and safety demonstration with supporting documents and reports
⇒ MDQMS Quality Management System compliance with ISO 13485
⇒ Notified Body submission and coordination Until successful completion
These services ensure that the device meets MDR regulatory expectations before submission.
CE Certification Service for In Vitro Diagnostic Devices
In Vitro Diagnostic devices are regulated under IVDR 2017/746, which introduced stricter regulatory requirements compared to the previous directive. All CE applicants (Legacy and New) often require special support from approved CE Certification Services providers to prepare the required documentation, including the following major sections
⇒ IVD classification (Class A, B, C, or D) and selection of Certification route and rule
⇒ Preparation of IVDR Technical Documentation File
⇒ Clinical Evaluation Report documentation with strong derivation of conclusion
⇒ Risk Management File documentation and risk mitigation as per ISO 14971
⇒ Biological Evaluation plan and safety demonstration with supporting documents and reports
⇒ MDQMS Quality Management System compliance with ISO 13485
⇒ Notified Body submission and coordination Until successful completion
Working with an experienced CE Certification Service provider helps manufacturers navigate these complex IVDR requirements.
Why Manufacturers Need Professional CE Certification Service providers
Many manufacturers face challenges when preparing regulatory documentation for CE certification. MDR and IVDR require detailed technical files, clinical evidence, and strict compliance with regulatory guidelines.
Without expert support, manufacturers may face delays, additional questions from Notified Bodies, or rejection during the review process.
A professional CE Certification Service helps ensure that documentation is prepared correctly and regulatory expectations are met.
Frequently Asked Questions
What is CE Certification?
CE certification is a solid proof that a medical device or IVD device meets European safety, health, and performance standards as prescribed in eu commission norms. Once the device obtains CE Certification, the manufacturer can fix CE logo on the device and can sell the product on the European Economic Area (EEA) market.