Medical Device CE Marking

CE marking is a process by which manufacturer demonstrates that the product has meets the applicable EU regulations for the device. Medical Device in Europe are regulated by EU MDR 2017/745 and in vitro Diagnostic Devices are regulated under EU MDR 2017/746

It is a legal requirement  for Medical device and IVD manufacturers to have CE marking before selling their product in Europe.

• Based on your product one needs to identify which regulations applies to your product ( EU MDR 2017/745 or EU MDR 2017/746)
• The applicant should then ideally classify the device and assess the requirements for the same.EU MDR for Medical Device classifies devices into Class I, Class IIA , Class IIB Class III  as per EU MDR classification rules
• Establish a Quality Management System (QMS) as this is a universal requirement for medical device manufacturers. Many companies follow ISO 13485 guidelines for QMS as starting point.
• Preparation of Technical File of the Medical device as per Directive requirement
• Facility Audited for QMS and technical file checked by a notified body , some class 1 devices are exempted from this and they can go for self-certification.

Notified bodies are 3^rd party companies accredited by EU Competent authority to conduct audits

• On Successful passing the audit and having a robust QMS with ISO 13485 certificate the Final Step is creating a Declaration of Conformity .This declaration is a legally binding document which declares that the device meets all the requirement of the directive and other regulatory standards.

After this one can affix the CE Symbol on the Device.

We at FDApals can help you at each step of CE Marking Process right from identification of respected directives and conformity assessment requirement to helping you implement a robust QMS system (ISO 13485) and preparation of Technical file. We also hand hold you for facing audits and resolving any NC.