Medical Device CE Mark is a Certification mark for Health, Safety and Environment protection standards to sell medical products in EEA (European Economic Area), CE mark is recognized worldwide. CE Mark is a declaration by manufacturers that, the products they are sell in EEA are meeting the requirements of EC Directives. In order to market products in the European market, the products must have a CE mark which declares that a product meets all relevant European Medical Device Directives.
The benefits of CE certification is that it is a legal requirement to trade your device in the European market.
The CE Mark is a conformity mark which all medical devices must have before they can be marketed. It is seen as a declaration by the manufacturer that the product meets all the provisions of the relevant directive. Devices are classified based on their contact.
What is CE Mark Technical File or Design Dossier Compilation and Review?
Compiling your technical file or design dossier is a critical step in Europe’s CE certification process and a requirement for compliance with the Medical Devices Directive 93/42/EEC. In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
CE Certification Process
We help you understand and meet the regulation to ensure your product completes the CE Marking process efficiently and successfully. And answer the questions. How to get ce mark for medical device ? and Medical Device CE Mark certification process.

Before the CE Mark may be affixed to a medical device and legally sold within the European Union, the manufacturer or exporter must complete the following:

Prepare Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment procedures of the applicable device directive
Register their device with the appropriate Competent Authorities
Receive a device-specific CE Certificate from a Notified Body (Class I devices do not require a certificate from a Notified Body)
Operon Strategist supports clients in meeting “European submission” standards that declares the product offered is in compliance with the Essential Requirements of relevant European safety, health and Environmental protecting regulation.
We are leading Medical Device CE Certification Consultant for medical device disposable implant manufacturers, medical disposable syringe manufacturers, surgical instrument manufacturers, orthopedic implant & instruments manufacturers, laboratory equipment manufacturers, sterilization equipment and accessories manufacturers, medical imaging systems manufacturers.
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2. disposable syringe manufacturers
3. Dental Implants Manufacturing
4.Blood Collection Tubes Manufacturing
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If You Want Medical Devices Services Consultation For Following.

1. Medical Device Manufacturing
2. CDSCO Registration
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4. Continuous Improvement Program
5. Design Control Requirements
6. QMS Certification Services
7. Manufacturing Plant Layout Design
8. Primary Packaging Consultant
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10. Combination Product
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12. Clean Room Design Consultant
13. ISO 13485 Certification
14. ISO 15378 certification
15. Medical Device Process Validation
16. 21 cfr part 820
17. 21 cfr part 210 and 211
18. DMF submission
19. CAPA Management
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