Concerning medical device manufacturing businesses, the entry to the European market is a plus. Nevertheless, it entails rigorous legal restraints which are crucial and among them is the CE check.
The importance of CE Marking for Medical Device Manufacturers, is due to the fact that it certifies that the product conforms to safety, health, and environmental regulations of the European Union (EU).
In I3CGlobal our CE marking services assist manufacturers to deal with these issues to make the certification process seamless.
What Is CE Marking?
CE Marking is a compliance mark for products, which like medical devices that are intended to be sold in the European Economic Area (EEA).
The CE Marking Approval is a mandatory indication that a product has undergone voluntary conformity assessment procedures of the EU safety, health, and environmental legislations.
It is necessary for medical device manufacturers to go through this certification process which involves technical documentation, clinical review and clinical evaluation of all classes of the medical devices plus risk analysis.
Role of CE Marking for Medical Devices Manufacturers
1. Market Access to Europe
Obtaining the CE Marking is compulsory before marketing medical devices in Europe. Indeed, the manufacturers of these products cannot legally supply their products in the EEA if they lack this certificate.
2. Safety and Quality Guarantee
CE marking means that different control authorities, medical practitioners, and users of a medical device can trust that the equipment complies with needed safety and quality requirements.
3. Competitive Advantage
Some medical devices, which are CE marked, are easy to compete in the world market. This certification brings into light compliance with international standards hence gives manufacturers a competitive advantage.
4. Simple Regulatory Procedures
This means that manufacturers whose aim is to grow their businesses internationally can use this Marking as a way of easily meeting other requirements of certifying for many other regulations. CE Marking is seen as a security mark; many countries accept it as a mark of safety and the quality of a product.
Main Procedures in the course of Marking Endorsement
- Classification of the Medical Device
Classification is done according to risks connected with devices which are divided into classes I, IIa, IIb or III, their certification evidence.
- Documentation Preparation
The manufacturer has to establish a technical file, which contains clinical evaluation documents, risk analysis and performance information.
- Conformity Assessment
In this context, this may require self-certification, but where a higher class has been placed upon the electrical or electronic equipment this may mandate the involvement of a notified body for third-party certification.
- Affixing the CE Mark
Once an economic operator has provided proof that it meets all relevant obligations under compliance, it can apply the CE marking to the device in question and thereby formally signifying conformity with EU requirements.
How I3CGlobal Supports CE Marking
Our professionals at I3CGlobal offer comprehensive CE Marking services to our clients. We are medical device regulatory consulting company in India and USA and provide complete regulatory compliance services. Our services include:
- Technical documentation as well as clinical evaluations.
- Helping manufactures to get a classification of the product in question and conforming to the right assessment procedure.
- Providing earthmoving machinery with post-certification assistance to adhere to the EU laws.
Hiring services with I3CGlobal CE marking service means that the manufacturer does not have to struggle when it comes to CE Marking while they deliver the innovative medical devices to the market.
Conclusion: Empowerment for Manufacturers’ Success
It is equally important to argue about the Importance of CE Marking for Medical Device Manufacturers. In the European Union it is the basis for compliance, safety and market access.
Besides fulfilling the requirements of CE certification, manufacturers equally build up confidence among end-users besides gaining competitive advantage all over the world.
To reduce cost and complexity of certified CE markings for medical devices, let I3CGlobal facilitate CE marking certifications for you.
Choose us as your partner to move to the next level of your way to the market. Get in touch with us and find out more!
