Steps for Getting CE Marking
All products meeting the definition of medical devices as defined by the EU regulations require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and meets EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
The product must comply with all the relevant MDD to MDR requirements of before affixing the CE marking to it. Although the compliance requirements are similar in many ways, the European route is thought to be less governmental, resulting in shorter times to market, greater acceptance rates of new devices, and lesser costs associated with obtaining conformity certification.
While the benefits of obtaining a CE marking are significant, regulations are always subject to change. New modifications to the European medical device requirements are making the process more similar to that of the FDA when it comes to establishing conformity.
By May 2021, a new Medical Device Regulation (MDR 2017/745) will go into effect throughout the European Union. Despite the changes, there still remains a clear path to establishing conformity and obtaining a CE marking that will allow your company to access European markets.
Steps
1. IDENTIFY THE APPLICABLE REQUIREMENTS OF THE REGULATIONS
1. CLASSIFY THE DEVICE AS PER THE RULES DEFINED FOR CLASSIFICATION OF MEDICAL DEVICES
2. IDENTIFY AN APPROPRIATE ROUTE TO CONFORMITY
3. ASSESSMENT OF THE PRODUCT’S CONFORMITY TO EU REQUIREMENTS
4. COMPILE THE TECHNICAL DOCUMENTATION, QMS & CLINICAL EVALUATION REPORT.
5. ASSESSMENT BY NOTIFIED BODY
6. MAKE A DECLARATION OF CONFORMITY AND AFFIX THE CE MARK
IZiel Healthcare has collaborated with Belgium based Obelis (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition.
IZiel-Obelis collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking by developing Technical File & QMS Documentation, conducting Software Validation, writing CERs and providing EC Rep, EUDAMED, PRRC Services. Our experts are well equipped to conduct this activity with an analytical mindset, resolve any engineering requirements and develop robust regulatory strategy for medical device manufacturers.
