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MEDICAL DEVICE CE MARKING PREMIUM SERVICES!

We never let you in dark. We accompany you till Medical Device CE Marking Completion.
According to the “Perga,” we are the best and well-established CE Marking Consultants in the Asia Pacific and the Middle East.
We have a strong presence in Asia (Malaysia, Vietnam, India), EU (Germany, UK) and the USA.
Technical Consultants

One among the largest pool of talented teams in the world.

Document Control

ISO 27001:2013 Certified data security system. NDA with team members.

Annual Maintenance

Technical files updated throughout the year by our team.

Medical Devices CE Marking Services!

Medical Device CE Marking signifies a product complies with the minimum requirements for medical device within the European Union. That is a manufacturer’s declaration that the product fulfils the general safety and performance requirements of the relevant European health and safety legislation.

 

When introducing a product to the market, there are specific requirements that must be met, and obtaining the CE marking is mandatory. Essentially, CE certification is a legal requirement governed by the legislation of the European Union market.

 

CE marking covers reusable devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes, spanning a diverse range of indications. We have the experience and expertise to prepare technical documentation and submit with any notified body of your choice.

Medical Device CE Marking Requirements!

All the medical device need to have CE marking, but some of the devices need to comply with some requirements. Maybe those devices cannot be CE marked. For example, custom-made devices are different from normal requirements.

 

They are custom-made for each and every patient. Medical Device CE Marking are different for each class. The simplest devices with less risk are very simple to CE mark but the high-risk class devices need a third party to check any documentation. Once our product CE marked, it can be sold anywhere in the European Union.

 

The basic process of Medical Device CE marking is needed to identify that product and what kind of regulations are needed for the device. Product risk classification is a very important requirement. The product needs to comply with the general safety and performance requirements, so these are a list of requirements that apply to every medical deviceS.

 

The medical device manufacturing process needs to be guided by harmonized standards. The conformity assessment procedure needs to be identified. Sometimes some risks are unavoidable, but the benefits will always outweigh the risks. If a manufacturer is outside the European Union, they must apply for medical device CE Marking via an European authorized representative.

Medical Device CE Marking Advantages

Medical Device CE Marking services are mandatory to enter the large European Union market of over 350 million wealthy consumers. Considering the advantages of CE marking, all manufacturers are forced to apply for CE certification, not only in Europe but also in other parts of the world. Large and corporate device manufacturers usually have sufficient staff in the regulatory affairs department.

 

In the case of small and medium-sized companies that do not have much technical expertise or full-time employees, they are confused and uncertain of what is required to obtain CE mark, including what documents and how much it will cost.

 

For small and medium-sized companies, it is difficult to prepare technical files because they usually lack knowledge and previous experience for the sizeable tasks involved as per MDR and IVDR documentation. Usually, this gesture and consultant role are vital.

Device Testing

Testing is essential to demonstrate General Safety and Performance of the device

European Representative

All Non European manufactures must appoint European Authorized Representative

EN ISO 13485:2016

MDQMS Implementation is mandatory of medium and high risk devices for CE Marking

In-Vitro Diagnostic Regulation

In Vitro Diagnostic Regulation (IVDR) is the new

Technical File

Technical Documentation or Technical File is to demonstrate the safety and performance of medical devices

Clinical Evaluation

MDR article 61 and MEDDEV Rev 4, must be documented and CER

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IVDR CE Marking Services

The European In Vitro Diagnostic Regulation (EU IVDR 2017/745) establishes a new regulatory framework for the placing of In Vitro Diagnostic Devices (IVDs) in the European market.

 

This regulation is poised to replace the current Directive on in vitro diagnostic devices (EU 98/79/EC). Being a European regulation, it automatically applies to all EU Member States and the European Free Trade Association.

 

  • IVDR EU 2017/746 Technical Documentation preparation, NB coordination, EC Representation
  • Performance Evaluation Report (PER) preparation along with testing in associated laboratories with assurance of NB approval (Article 56 and Annex XIII, Part B)
  • Post market Performance Follow-up (PMPF) as per the Annex XIII Part B of the IVDR (Article 80)
  • Post Market Surveillance (PMS) Report as per Article 80
  • Vigilance Reporting as per the Article 82 of the IVDR
  • Summary of Safety and Performance (Article 29)

 

As a trusted regulatory partner, I3CGLOBAL offers comprehensive EU IVDR consulting services ensuring early CE Certification for Vitro Diagnostic Devices.

Why to Choose us for MDR & IVDR CE Marking Services?

We are a premium regulatory compliance solutions provider for medical and in-vitro diagnostic device, specialising in Medical Device CE Marking Services. Today, manufacturers are faced with challenges from regulatory authorities.

 

They require additional technical support and expert manpower to develop and engage with the Notified Bodies as well as to maintain the validity of the CE certificate once issued. That’s where we come in!!

European Free Sale Certificate

The European Free Sale Certificate (FSC) or the Certificate of Free Sale (CFS) is the evidence

MDR & IVDR Classification

New MDR & IVDR regulations has made significant changes compared to previous (Directive) classification system

MDR & IVDR CE Marking Timeline

Standard dummy text ever to the since the 1500s, when an unknown the printer took a galley.

MDR & IVDR Notified Body List

MDR & IVDR Up-to-date information of notification status of Notified Bodies can be found

EUDAMED Registration

NB process EUDAMED is the European Database an IT system proposed by the European Commission

Unique Device Identification

Unique Device Identification (UDI) system helps in device identification and facilitate the traceability of devices.

Systems and Procedure Packs

CE Marking of "Systems" or "Procedure Packs" or "Kits" detailed in MDR 2017/745 article 22

Vigilance Control System

Manufacturers legally obligated to report serious incidents and Field Safety Corrective Action as per MDR Section 2, article 87.

Sterile Medical Devices

Notified Body process detailing the requirement of the MDR relating to a device have been fulfilled

Medical Device Usability

Usability refers to the user interface characteristic which establishes user learning and user satisfaction,

Medical Device Labeling

Medical Devices labelling is complex and needs appropriate information and knowledge how and what

General Safety & Performance

EU MDR replaces the essential requirements (ER) by general safety and performance requirements